Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
Sponsor
Emory University (Other)
Overall Status
Terminated
CT.gov ID
NCT03040024
Collaborator
(none)
71
1
3
37.3
1.9
Study Details
Study Description
Brief Summary
The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a single center prospective randomized double blinded placebo controlled study.
The primary aim of the study is to optimize the intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction. Secondary aims are to determine the dose response relationship for intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will reduce post-operative pain and opioid requirements, determine if raw electroencephalogram (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate length of intensive care unit (ICU) and length of hospital stay.
Participants will be randomized to one of three groups after administration of general anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV placebo.
An EEG will be used during the surgical procedure to gather raw data for off line analysis among patients developing post-operative delirium.
Study Design
Study Type:
Interventional
Actual Enrollment
:
71 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
Actual Study Start Date
:
Mar 17, 2017
Actual Primary Completion Date
:
Feb 24, 2020
Actual Study Completion Date
:
Apr 24, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ketamine 0.5 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. |
Drug: Ketamine
Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Device: Electroencephalogram (EEG)
A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
|
| Experimental: Ketamine 1.0 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. |
Drug: Ketamine
Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Device: Electroencephalogram (EEG)
A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
|
| Placebo Comparator: Placebo Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. |
Drug: Placebo
Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Other Names:
Device: Electroencephalogram (EEG)
A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
|
Outcome Measures
Primary Outcome Measures
- Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score [Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)]
The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.
Secondary Outcome Measures
- Change in Behavioral Pain Scale (Non-Intubated) Score [Post Operation (Up to 6 Hours), Post Operation Day 0]
The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).
- Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score [Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)]
Scores range from 0 (no pain) to 10 (worst pain).
- Change in Mini Cog Score [Baseline, Post Surgery (Up to 6 Weeks)]
The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.
- Change in Mini-Mental Status Examination (MMSE) Score [Baseline, Post Surgery (Up to 6 Weeks)]
The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.
- Change in Cognitive Failure Questionnaire (CFQ) Score [Baseline, Post Surgery (Up to 6 Weeks)]
The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.
- Post Operative Narcotics Use [Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)]
The total amount of narcotics used measured in morphine milligram equivalents (MME).
- Associations of Intraoperative EEG Patterns With PACU Delirium [Intraoperative EEG and delirium during PACU stay]
The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia
-
Competent to provide informed consent
Exclusion Criteria:
-
Emergency surgery
-
Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia)
-
Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement
-
Poor health literacy
-
Allergy, or have experienced any drug reaction to ketamine
-
Pregnant or lactating
-
Currently in active alcohol withdrawal
-
Taking buprenorphine for chronic pain
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
Sponsors and Collaborators
- Emory University
Investigators
- Principal Investigator: Vanessa Moll, PhD, Emory University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Amit Prabhakar,
Assistant Professor,
Emory University
ClinicalTrials.gov Identifier:
NCT03040024
Other Study ID Numbers:
- IRB00086609
First Posted:
Feb 1, 2017
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Amit Prabhakar,
Assistant Professor,
Emory University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Period Title: Overall Study | |||
| STARTED | 21 | 26 | 24 |
| COMPLETED | 21 | 24 | 23 |
| NOT COMPLETED | 0 | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Total of all reporting groups |
| Overall Participants | 21 | 26 | 24 | 71 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
63.7
(8.6)
|
64.6
(12.4)
|
64.5
(11.5)
|
64.3
(10.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
9
42.9%
|
8
30.8%
|
8
33.3%
|
25
35.2%
|
| Male |
12
57.1%
|
18
69.2%
|
16
66.7%
|
46
64.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
1
4.8%
|
0
0%
|
0
0%
|
1
1.4%
|
| Not Hispanic or Latino |
20
95.2%
|
26
100%
|
24
100%
|
70
98.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
3.8%
|
0
0%
|
1
1.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
9.5%
|
4
15.4%
|
4
16.7%
|
10
14.1%
|
| White |
18
85.7%
|
21
80.8%
|
20
83.3%
|
59
83.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
4.8%
|
0
0%
|
0
0%
|
1
1.4%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
21
100%
|
26
100%
|
24
100%
|
71
100%
|
Outcome Measures
| Title | Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score |
|---|---|
| Description | The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame. |
| Time Frame | Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal) |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 17 | 22 | 17 |
| Delirium CAM-ICU Score at PACU Arrival |
11
52.4%
|
9
34.6%
|
9
37.5%
|
| No Delirium CAM-ICU Score at PACU Arrival |
6
28.6%
|
13
50%
|
10
41.7%
|
| Delirium CAM-ICU Score at PACU Discharge |
6
28.6%
|
5
19.2%
|
2
8.3%
|
| No Delirium CAM-ICU Score at PACU Discharge |
11
52.4%
|
17
65.4%
|
15
62.5%
|
| Title | Change in Behavioral Pain Scale (Non-Intubated) Score |
|---|---|
| Description | The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain). |
| Time Frame | Post Operation (Up to 6 Hours), Post Operation Day 0 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unable to collect information for this outcome. The investigators collected the pain scales from the EMR. The BPS was not routinely collected in the hospital and they only report Visual analog scale (VAS). |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 0 | 0 | 0 |
| Title | Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score |
|---|---|
| Description | Scores range from 0 (no pain) to 10 (worst pain). |
| Time Frame | Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 21 | 26 | 24 |
| Baseline Pain Level assessed by the Visual Analog Scale (VAS) Score |
3.50
(3.25)
|
4.36
(2.94)
|
2.30
(2.88)
|
| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (PACU) |
1.00
(2.45)
|
2.56
(3.28)
|
1.63
(3.11)
|
| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0) |
4.76
(3.86)
|
4.22
(3.24)
|
3.62
(3.74)
|
| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1) |
3.93
(2.76)
|
3.72
(2.55)
|
3.52
(2.42)
|
| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2) |
2.47
(2.52)
|
2.81
(2.51)
|
3.38
(2.62)
|
| Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3) |
3.08
(2.94)
|
3.35
(2.15)
|
3.41
(2.20)
|
| Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks) |
2.3
(2.58)
|
3.09
(2.68)
|
3.00
(2.60)
|
| Title | Change in Mini Cog Score |
|---|---|
| Description | The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia. |
| Time Frame | Baseline, Post Surgery (Up to 6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants is different from participant flow because some of the subjects did not complete the assessment. |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 20 | 25 | 24 |
| Baseline Mini Cog Score- Positive Screen |
2
9.5%
|
5
19.2%
|
6
25%
|
| Baseline Mini Cog Score- Negative Screen |
18
85.7%
|
20
76.9%
|
18
75%
|
| Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen |
3
14.3%
|
0
0%
|
3
12.5%
|
| Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen |
17
81%
|
23
88.5%
|
17
70.8%
|
| Title | Change in Mini-Mental Status Examination (MMSE) Score |
|---|---|
| Description | The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment. |
| Time Frame | Baseline, Post Surgery (Up to 6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed. |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 20 | 25 | 24 |
| Normal Baseline MMSE Score (25-30) |
18
85.7%
|
22
84.6%
|
22
91.7%
|
| Cognitive Impairment Baseline MMSE Score (0-24) |
2
9.5%
|
3
11.5%
|
2
8.3%
|
| Normal Post surgery (Up to 6 weeks) MMSE Score (25-30) |
17
81%
|
23
88.5%
|
16
66.7%
|
| Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24) |
3
14.3%
|
0
0%
|
4
16.7%
|
| Title | Change in Cognitive Failure Questionnaire (CFQ) Score |
|---|---|
| Description | The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention. |
| Time Frame | Baseline, Post Surgery (Up to 6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed. |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 20 | 25 | 24 |
| Baseline CFQ Score |
27
|
34
|
30
|
| CFQ Score Post surgery (Up to 6 weeks) |
29
|
30
|
29
|
| Title | Post Operative Narcotics Use |
|---|---|
| Description | The total amount of narcotics used measured in morphine milligram equivalents (MME). |
| Time Frame | Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population is different at 6 weeks post intervention because this outcome was not completed for some participants at that time point. |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 21 | 26 | 24 |
| Post Intervention (Intraoperative) |
13.3
|
13.3
|
13.33
|
| Post Intervention (POD 0) |
7.1
|
6.67
|
6.18
|
| Post Intervention (POD 1) |
35
|
41.5
|
42.9
|
| Post Intervention (POD 2) |
8.59
|
25.7
|
41.9
|
| Post Intervention (POD 3) |
19.8
|
34.3
|
34.3
|
| Post Intervention (Follow up visit-up to 6 weeks) |
0
|
0
|
0
|
| Title | Associations of Intraoperative EEG Patterns With PACU Delirium |
|---|---|
| Description | The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown. |
| Time Frame | Intraoperative EEG and delirium during PACU stay |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only a total of 38 EEGs with sufficient quality were analyzed |
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
| Measure Participants | 18 | 9 | 11 |
| Positive Delirium for PACU |
10.0
(5.0)
|
7.0
(5.0)
|
7.0
(6.0)
|
| Negative Delirium for PACU |
7.0
(1.0)
|
5.0
(6.0)
|
6.0
(4.0)
|
Adverse Events
| Time Frame | The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE. | |||||
| Arm/Group Title | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo | |||
| Arm/Group Description | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. | |||
All Cause Mortality |
||||||
| Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 1/26 (3.8%) | 0/24 (0%) | |||
Serious Adverse Events |
||||||
| Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/21 (19%) | 9/26 (34.6%) | 2/24 (8.3%) | |||
| Cardiac disorders | ||||||
| NSTEMI | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Dysphagia | 1/21 (4.8%) | 1 | 0/26 (0%) | 0 | 0/24 (0%) | 0 |
| Infections and infestations | ||||||
| Sepsis | 0/21 (0%) | 0 | 0/26 (0%) | 0 | 0/24 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Surgical wound dehiscence | 1/21 (4.8%) | 1 | 0/26 (0%) | 0 | 0/24 (0%) | 0 |
| Post-operative wound abscess | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Partial flap necrosis | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Exposed tendon of left forearm free flap | 1/21 (4.8%) | 1 | 0/26 (0%) | 0 | 0/24 (0%) | 0 |
| Nervous system disorders | ||||||
| Delirium | 1/21 (4.8%) | 1 | 0/26 (0%) | 0 | 1/24 (4.2%) | 1 |
| Stroke | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Bilateral MCA; PCA transcortical acute infarcts | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Respiratory Failure | 0/21 (0%) | 0 | 3/26 (11.5%) | 3 | 0/24 (0%) | 0 |
| Vascular disorders | ||||||
| Facial artery clot | 0/21 (0%) | 0 | 0/26 (0%) | 0 | 1/24 (4.2%) | 1 |
| Carotid injury | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/21 (14.3%) | 5/26 (19.2%) | 4/24 (16.7%) | |||
| General disorders | ||||||
| Somnolence | 0/21 (0%) | 0 | 0/26 (0%) | 0 | 1/24 (4.2%) | 1 |
| Restlessness | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Nervous system disorders | ||||||
| Agitation | 1/21 (4.8%) | 1 | 2/26 (7.7%) | 2 | 0/24 (0%) | 0 |
| Transient left sided weakness | 1/21 (4.8%) | 1 | 0/26 (0%) | 0 | 0/24 (0%) | 0 |
| Psychiatric disorders | ||||||
| Anxiety | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
| Hallucinations | 0/21 (0%) | 0 | 0/26 (0%) | 0 | 1/24 (4.2%) | 1 |
| Depression | 1/21 (4.8%) | 1 | 0/26 (0%) | 0 | 0/24 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Respiratory distress | 0/21 (0%) | 0 | 0/26 (0%) | 0 | 2/24 (8.3%) | 2 |
| Vascular disorders | ||||||
| Hypertension | 0/21 (0%) | 0 | 1/26 (3.8%) | 1 | 0/24 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
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.
Results Point of Contact
| Name/Title | Dr. Amit Prabhakar |
|---|---|
| Organization | Emory University |
| Phone | 404-686-2747 |
| amit.prabhakar@emory.edu |
Responsible Party:
Amit Prabhakar,
Assistant Professor,
Emory University
ClinicalTrials.gov Identifier:
NCT03040024
Other Study ID Numbers:
- IRB00086609
First Posted:
Feb 1, 2017
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021