Lidocaine For Neuroprotection During Cardiac Surgery

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00938964
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), CAS Medical Systems, Inc. (Industry)
• Enrollment: 550
• Locations: 2
• Arms: 2
• Actual Duration (Months): 94.7
• Patients Per Site: 275
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline	Drug: Lidocaine; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Lidocaine For Neuroprotection During Cardiac Surgery
• Actual Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jul 18, 2016
• Actual Study Completion Date: May 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine Lidocaine infusion for 48 hours	Drug: Lidocaine; Lidocaine versus placebo infusion for 48 hours
Placebo Comparator: Placebo Normal saline infusion for 48 hours	Drug: Placebo; Lidocaine versus placebo infusion for 48 hours

Outcome Measures

Primary Outcome Measures

1. Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change [Preoperative to 6 weeks after surgery]

   To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.

2. Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome [Preoperative to 6 weeks after surgery]

   To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.

Secondary Outcome Measures

1. Transcerebral Activation Gradients of Platelets [Baseline to 6 hours post cross-clamp removal]

   Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups

2. Transcerebral Activation Gradients of Neutrophils [Baseline to 6 hours post cross-clamp removal]

   Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups

3. Transcerebral Activation Gradients of Monocytes [Baseline to 6 hours post cross-clamp removal]

   Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups

4. Transcerebral Activation Gradient of Platelet-neutrophil Conjugates [Baseline to 6 hours post cross-clamp removal]

   Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups

5. Change in Cognitive Function From Baseline [1 year after surgery]

   To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement

6. Change in Duke Activity Status Index (DASI) [baseline, 6-weeks]

   The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.

7. Change in Duke Activity Status Index (DASI) [baseline, 1-year]

   The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.

8. Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) [baseline, 6-weeks]

   The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).

9. Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS) [baseline, 1-year]

   The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).

10. Change in Center for Epidemiological Studies Depression Scale (CES-D) [baseline, 6-weeks]

    Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.

11. Change in Center for Epidemiological Studies Depression Scale (CES-D) [baseline, 1-year]

    Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.

12. Change in Spielberger State Anxiety Inventory (STAI) [baseline, 6-weeks]

    Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety.

13. Change in Spielberger State Anxiety Inventory (STAI) [baseline, 1-year]

    Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety.

14. Change in Symptom Limitations [baseline, 6-weeks]

    Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.

15. Change in Symptom Limitations [baseline, 1-year]

    Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.

16. Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) [baseline, 6-weeks]

    Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.

17. Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL) [baseline, 1-year]

    Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.

18. Change in the Cognitive Difficulties Scale [baseline, 6-weeks]

    Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.

19. Change in the Cognitive Difficulties Scale [baseline, 1-year]

    Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.

20. Change in Perceived Social Support [baseline, 6-weeks]

    Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support.

21. Change in Perceived Social Support [baseline, 1-year]

    Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support.

22. Change in Social Activity [baseline, 6-weeks]

    Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity.

23. Change in Social Activity [baseline, 1-year]

    Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity.

24. Change in Study 36-Item Short Form Health Survey (SF-36) [baseline, 6-weeks]

    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.

25. Change in Study 36-Item Short Form Health Survey (SF-36) [baseline, 1-year]

    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.

26. Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) [baseline, 6-weeks]

    The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.

27. Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS) [baseline, 1-year]

    The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. CABG, CABG + Valve, or Valve surgery

2. Use of cardiopulmonary bypass

Exclusion Criteria:

1. Less than 50 years of age

2. History of diabetes

3. History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual deficit

4. Alcoholism (> 2 drinks/day)

5. History of psychiatric illness (any clinical diagnoses requiring therapy)

6. History of drug abuse (any illicit drug use in the past 3 months)

7. Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)

8. Severe pulmonary insufficiency (requiring home oxygen therapy)

9. Renal failure (baseline serum creatinine > 2.0 mg/dl)

10. Pregnant women

11. Unable to read and thus unable to complete the cognitive testing

12. Score < 24 on a baseline Mini Mental State examination (MMSE) or greater than or equal to 27 on the baseline Center for Epidemiological Studies Depression (CES-D) Scale -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710
2	Sentara Cardiovascular Research Institute	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Duke University
• National Heart, Lung, and Blood Institute (NHLBI)
• CAS Medical Systems, Inc.

Investigators

• Principal Investigator: Joseph P Mathew, M. D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00938964
• Other Study ID Numbers: Pro00015641; R01HL096978
• First Posted: Jul 14, 2009
• Last Update Posted: May 10, 2019
• Last Verified: May 1, 2019

• Keywords provided by Duke University: Cognition
• Additional relevant MeSH terms: Cognitive Dysfunction; Lidocaine

Study Results

Participant Flow

Recruitment Details	550 participants consented; 478 participants were randomized.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Period Title: Overall Study
STARTED	241	237
COMPLETED	211	209
NOT COMPLETED	30	28

Baseline Characteristics

Arm/Group Title	Lidocaine	Placebo	Total
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours	Total of all reporting groups
Overall Participants	211	209	420
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.9 (9.1)	66.5 (9.5)	66.7 (9.3)
Sex: Female, Male (Count of Participants)
Female	60 28.4%	49 23.4%	109 26%
Male	151 71.6%	160 76.6%	311 74%
Region of Enrollment (Count of Participants)
United States	211 100%	209 100%	420 100%

Outcome Measures

1. Primary Outcome

Title	Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change
Description	To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.
Time Frame	Preoperative to 6 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	0.07 (0.32)	0.07 (0.37)

2. Primary Outcome

Title	Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome
Description	To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.
Time Frame	Preoperative to 6 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Count of Participants [Participants]	87 41.2%	83 39.7%

3. Secondary Outcome

Title	Transcerebral Activation Gradients of Platelets
Description	Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame	Baseline to 6 hours post cross-clamp removal

Outcome Measure Data

Analysis Population Description

Planned substudy, that was analyzed after 202 enrolled subjects

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	105	97
Baseline	-0.03 (0.79)	0.35 (1.91)
Cross-clamp removal	0.03 (1.21)	0.43 (1.44)
End of Bypass	0.33 (3.25)	0.05 (2.65)
6 hours post cross-clamp removal	0.37 (2.65)	0.27 (1.07)

4. Secondary Outcome

Title	Transcerebral Activation Gradients of Neutrophils
Description	Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame	Baseline to 6 hours post cross-clamp removal

Outcome Measure Data

Analysis Population Description

Planned substudy, that was analyzed after 202 enrolled subjects

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	105	97
Baseline	-2.02 (8.15)	-0.08 (9.17)
Cross-clamp removal	0.56 (6.82)	0.17 (5.53)
End of Bypass	0.58 (4.54)	1.19 (6.76)
6 hours post cross-clamp removal	1.04 (7.08)	-0.68 (8.61)

5. Secondary Outcome

Title	Transcerebral Activation Gradients of Monocytes
Description	Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame	Baseline to 6 hours post cross-clamp removal

Outcome Measure Data

Analysis Population Description

Planned substudy, that was analyzed after 202 enrolled subjects.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	105	97
Baseline	-4.22 (19.10)	-0.04 (17.78)
Cross-clamp removal	-2.46 (16.94)	1.83 (16.80)
End of Bypass	-0.34 (19.57)	2.64 (15.69)
6 hours post cross-clamp removal	1.21 (15.08)	0.54 (13.69)

6. Secondary Outcome

Title	Transcerebral Activation Gradient of Platelet-neutrophil Conjugates
Description	Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame	Baseline to 6 hours post cross-clamp removal

Outcome Measure Data

Analysis Population Description

Planned substudy, that was analyzed after 202 enrolled subjects.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	105	97
Baseline	-0.15 (9.64)	-0.43 (8.40)
Cross-clamp removal	0.02 (4.33)	-0.73 (3.97)
End of Bypass	-0.73 (4.99)	-0.40 (5.12)
6 hours post cross-clamp removal	-0.10 (5.40)	0.19 (4.73)

7. Secondary Outcome

Title	Change in Cognitive Function From Baseline
Description	To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	0.09 (0.34)	0.07 (0.34)

8. Secondary Outcome

Title	Change in Duke Activity Status Index (DASI)
Description	The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	-10.98 (15.4)	-11.67 (16.8)

9. Secondary Outcome

Title	Change in Duke Activity Status Index (DASI)
Description	The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done "with no difficulty" receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	6.3 (18.3)	6.96 (16.9)

10. Secondary Outcome

Title	Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
Description	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	0.05 (0.5)	0.04 (0.5)

11. Secondary Outcome

Title	Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
Description	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	0.05 (0.70)	0.07 (0.60)

12. Secondary Outcome

Title	Change in Center for Epidemiological Studies Depression Scale (CES-D)
Description	Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	0.57 (7.5)	0.16 (8.3)

13. Secondary Outcome

Title	Change in Center for Epidemiological Studies Depression Scale (CES-D)
Description	Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as "I had crying spells" and "I felt lonely." Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	-1.27 (7.7)	-0.89 (7.9)

14. Secondary Outcome

Title	Change in Spielberger State Anxiety Inventory (STAI)
Description	Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	-7.12 (12.1)	-6.31 (11.4)

15. Secondary Outcome

Title	Change in Spielberger State Anxiety Inventory (STAI)
Description	Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as "I feel nervous" and "I feel worried." These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from "not at all" to "very much so." Scores range from 20 to 80, with higher scores indicating greater anxiety.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	-6.70 (12.7)	-6.39 (10.3)

16. Secondary Outcome

Title	Change in Symptom Limitations
Description	Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	-0.67 (4.0)	-0.8 (3.9)

17. Secondary Outcome

Title	Change in Symptom Limitations
Description	Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	-1.39 (3.8)	-1.48 (3.8)

18. Secondary Outcome

Title	Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)
Description	Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	2.46 (4.2)	2.1 (3.9)

19. Secondary Outcome

Title	Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)
Description	Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., "Could you prepare your own meals?" "Could you drive a car?"). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	-0.15 (2.1)	-0.31 (2.6)

20. Secondary Outcome

Title	Change in the Cognitive Difficulties Scale
Description	Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	-3 (14.6)	-3.21 (15.9)

21. Secondary Outcome

Title	Change in the Cognitive Difficulties Scale
Description	Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are "I forget errands I planned to do" and "I fail to recognize people I know." Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	-0.46 (16.1)	-1.02 (17)

22. Secondary Outcome

Title	Change in Perceived Social Support
Description	Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	1.23 (14)	-0.49 (13.9)

23. Secondary Outcome

Title	Change in Perceived Social Support
Description	Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is "a special person who is around when I am in need" and "my family really tries to help me." Choices range from "very strongly disagree" to "very strongly agree." Items are summed for a range of 12 to 84, with a high score meaning more social support.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	0.71 (13.4)	-1.16 (12.9)

24. Secondary Outcome

Title	Change in Social Activity
Description	Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	0.95 (3.4)	1.59 (3.2)

25. Secondary Outcome

Title	Change in Social Activity
Description	Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are "How often do you talk on the telephone with friends and relatives?" and "How often do you attend meetings of social groups, clubs, or civic organizations?" Scores range from 8 to 32. A lower score indicates more social activity.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	-0.20 (3.2)	0.03 (3.4)

26. Secondary Outcome

Title	Change in Study 36-Item Short Form Health Survey (SF-36)
Description	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
6-Week Change Work activities	2.71 (4.9)	3 (4.3)
6-Week Change General health perception	-0.004 (1.3)	-0.03 (1.2)

27. Secondary Outcome

Title	Change in Study 36-Item Short Form Health Survey (SF-36)
Description	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
1 year Change Work Activities	-1.37 (4.3)	-1.42 (4.1)
1 year Change General health perception	-0.28 (1.2)	-0.43 (1.1)

28. Secondary Outcome

Title	Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
Description	The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.
Time Frame	baseline, 6-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	211	209
Mean (Standard Deviation) [units on a scale]	0.04 (1.10)	-0.01 (1.3)

29. Secondary Outcome

Title	Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
Description	The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.
Time Frame	baseline, 1-year

Outcome Measure Data

Analysis Population Description

There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.

Arm/Group Title	Lidocaine	Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours	Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
Measure Participants	185	192
Mean (Standard Deviation) [units on a scale]	0.02 (1.10)	-0.02 (1.20)

Adverse Events

Time Frame	Adverse events were collected until hospital discharge (approximately 4 -10 days) . Serious Adverse Events were reported up to one year.
Arm/Group Title	Lidocaine		Placebo
Arm/Group Description	Lidocaine infusion for 48 hours Lidocaine: Lidocaine versus placebo infusion for 48 hours		Normal saline infusion for 48 hours Placebo: Lidocaine versus placebo infusion for 48 hours
All Cause Mortality
	Lidocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/241 (2.5%)		7/237 (3%)
Serious Adverse Events
	Lidocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	105/241 (43.6%)		103/237 (43.5%)
Blood and lymphatic system disorders
Acute Blood Loss anemia	4/241 (1.7%)	4	3/237 (1.3%)	3
Bleeding	6/241 (2.5%)	6	7/237 (3%)	7
Chylothorax	0/241 (0%)	0	1/237 (0.4%)	1
Coagulopathy	0/241 (0%)	0	2/237 (0.8%)	2
Thrombocytopenia	8/241 (3.3%)	8	8/237 (3.4%)	8
Cardiac disorders
Atrial Dysrhythmia - Atrial Fibrillation	41/241 (17%)	41	41/237 (17.3%)	41
Atrial Dysrhythmia -Sinus Bradycardia	0/241 (0%)	0	4/237 (1.7%)	4
AV Block	1/241 (0.4%)	1	1/237 (0.4%)	1
Bradycardia	1/241 (0.4%)	1	2/237 (0.8%)	2
Cardiac Arrest	1/241 (0.4%)	1	0/237 (0%)	0
Cardiac Tamponade	1/241 (0.4%)	1	0/237 (0%)	0
Cardiogenic Shock	0/241 (0%)	0	4/237 (1.7%)	4
Complete heart block	7/241 (2.9%)	7	6/237 (2.5%)	6
Congestive Heart Failure	2/241 (0.8%)	2	0/237 (0%)	0
Heart attack-hospitalization	0/241 (0%)	0	1/237 (0.4%)	1
Heart failure	1/241 (0.4%)	1	2/237 (0.8%)	2
Hemorrhagic shock	2/241 (0.8%)	2	0/237 (0%)	0
Hypertension	6/241 (2.5%)	6	2/237 (0.8%)	2
Hypotension	8/241 (3.3%)	8	7/237 (3%)	7
Hypovolemic shock	1/241 (0.4%)	1	0/237 (0%)	0
Junctional rhythm	5/241 (2.1%)	5	3/237 (1.3%)	3
Left bundle branch block	0/241 (0%)	0	1/237 (0.4%)	1
PEA Arrest	1/241 (0.4%)	1	0/237 (0%)	0
Pericarditis	0/241 (0%)	0	3/237 (1.3%)	3
Pulseless electrical activity	0/241 (0%)	0	1/237 (0.4%)	2
Shock	0/241 (0%)	0	1/237 (0.4%)	1
Sinus tachycardia	3/241 (1.2%)	3	2/237 (0.8%)	2
Syncope	0/241 (0%)	0	1/237 (0.4%)	1
Trifascicular block	0/241 (0%)	0	1/237 (0.4%)	1
Ventricular Dysrhythmia - Ventricular Tachycardia	2/241 (0.8%)	2	5/237 (2.1%)	5
Ventricular ectopy	1/241 (0.4%)	1	0/237 (0%)	0
Gastrointestinal disorders
GI Bleed	2/241 (0.8%)	2	0/237 (0%)	0
Ileus	2/241 (0.8%)	2	6/237 (2.5%)	6
Irritable bowel syndrome	1/241 (0.4%)	1	0/237 (0%)	0
Nausea/Vomiting/Constipation	0/241 (0%)	0	4/237 (1.7%)	4
General disorders
Fluid overload	1/241 (0.4%)	1	1/237 (0.4%)	1
Pain	1/241 (0.4%)	1	1/237 (0.4%)	1
Prolonged hospitalization	1/241 (0.4%)	1	0/237 (0%)	0
re-admission after fall	2/241 (0.8%)	2	0/237 (0%)	0
Immune system disorders
Anaphylatic or Anaphylactoid rxn	1/241 (0.4%)	1	0/237 (0%)	0
Fever of Non-Specified Origin	0/241 (0%)	0	1/237 (0.4%)	1
Phlebitis	1/241 (0.4%)	1	1/237 (0.4%)	1
Tranfusion rxn	0/241 (0%)	0	1/237 (0.4%)	1
Infections and infestations
Bacermia/sepsis	1/241 (0.4%)	1	0/237 (0%)	0
Haemophilus Influenzae	1/241 (0.4%)	1	0/237 (0%)	0
Infection	2/241 (0.8%)	2	0/237 (0%)	0
Leukocytosis	8/241 (3.3%)	8	7/237 (3%)	7
MRSA	2/241 (0.8%)	2	0/237 (0%)	0
Sternal Wound Infection	1/241 (0.4%)	1	0/237 (0%)	0
Thrush	0/241 (0%)	0	1/237 (0.4%)	1
Ventilator associated pneumonia	1/241 (0.4%)	1	0/237 (0%)	0
Injury, poisoning and procedural complications
Diaphragmic tear	1/241 (0.4%)	1	0/237 (0%)	0
Pulmonary contusion	3/241 (1.2%)	3	0/237 (0%)	0
Metabolism and nutrition disorders
Hyperkalemia	1/241 (0.4%)	1	0/237 (0%)	0
Hypokalemia	1/241 (0.4%)	1	0/237 (0%)	0
Hyponatremia	1/241 (0.4%)	1	2/237 (0.8%)	2
Lactic acidosis	1/241 (0.4%)	1	0/237 (0%)	0
Metabolic acidosis	0/241 (0%)	0	1/237 (0.4%)	1
Protein malnutrition	0/241 (0%)	0	1/237 (0.4%)	1
Nervous system disorders
Aphasia	0/241 (0%)	0	1/237 (0.4%)	1
Confusion/encephalopathy	0/241 (0%)	0	1/237 (0.4%)	1
Continuous coma	1/241 (0.4%)	1	0/237 (0%)	0
Dysphagia	1/241 (0.4%)	1	1/237 (0.4%)	1
Hypothermia	0/241 (0%)	0	1/237 (0.4%)	1
Left vocal cord palsy	0/241 (0%)	0	1/237 (0.4%)	1
Parkinson's disease	0/241 (0%)	0	1/237 (0.4%)	1
Renal and urinary disorders
Acute Urinary Retention	0/241 (0%)	0	1/237 (0.4%)	1
Acute Kidney Injury	2/241 (0.8%)	2	6/237 (2.5%)	6
Hematuria	1/241 (0.4%)	1	0/237 (0%)	0
Renal Failure	1/241 (0.4%)	1	1/237 (0.4%)	1
Renal Insufficiency	7/241 (2.9%)	7	5/237 (2.1%)	5
Urinary Tract Infection	3/241 (1.2%)	3	1/237 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Bronchitis	0/241 (0%)	0	1/237 (0.4%)	1
Hemoptysis	0/241 (0%)	0	1/237 (0.4%)	1
Hemothorax	2/241 (0.8%)	2	0/237 (0%)	0
Hypoxemia	3/241 (1.2%)	3	1/237 (0.4%)	1
Pleural Effusion	5/241 (2.1%)	5	6/237 (2.5%)	6
Pneumonia	2/241 (0.8%)	2	2/237 (0.8%)	2
Pneumothorax	1/241 (0.4%)	1	1/237 (0.4%)	1
Pulmonary congestion	0/241 (0%)	0	1/237 (0.4%)	1
Pulmonary Edema	2/241 (0.8%)	2	5/237 (2.1%)	5
Respiratory Distress	1/241 (0.4%)	1	2/237 (0.8%)	2
Respiratory Failure	4/241 (1.7%)	4	6/237 (2.5%)	6
Subcutaneous Air	1/241 (0.4%)	1	0/237 (0%)	0
Ventilation > 48hr	1/241 (0.4%)	1	0/237 (0%)	0
Surgical and medical procedures
Left brachial embolectomy	1/241 (0.4%)	1	0/237 (0%)	0
Left pleural effusion thoracentesis	0/241 (0%)	0	1/237 (0.4%)	1
LVAD	0/241 (0%)	0	1/237 (0.4%)	1
Pacemaker Placement	6/241 (2.5%)	6	8/237 (3.4%)	8
Reexploration For Bleeding	4/241 (1.7%)	4	4/237 (1.7%)	4
Reintubation	0/241 (0%)	0	1/237 (0.4%)	1
Suprapubic catheter placement	0/241 (0%)	0	1/237 (0.4%)	1
Thoracentesis	0/241 (0%)	0	2/237 (0.8%)	2
Vascular disorders
Deep Vein Thrombosis	0/241 (0%)	0	2/237 (0.8%)	2
Stroke	2/241 (0.8%)	2	6/237 (2.5%)	6
Other (Not Including Serious) Adverse Events
	Lidocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/241 (14.1%)		34/237 (14.3%)
Cardiac disorders
Atrial Dysrhythmia - Atrial Fibrillation	34/241 (14.1%)	34	34/237 (14.3%)	34

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.