RemivsDex: A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01269918
• Collaborator: (none)
• Enrollment: 142
• Locations: 2
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 71
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.

Condition or Disease	Intervention/Treatment	Phase
Adult Intracranial Tumor; Adult Solid Tumor	Drug: Remifentanil; Drug: Dexmedetomidine	N/A

Detailed Description

Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia. At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation. Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain. (2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remifentanil Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	Drug: Remifentanil; Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS; Other Names: Ultiva, G187084B
Active Comparator: Dexmedetomidine a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.	Drug: Dexmedetomidine; a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.; Other Names: Precedex, Dexmedetomidine Hydrochloride

Outcome Measures

Primary Outcome Measures

1. Hemodynamics [15, 30, 45, 60, and 90 minutes after extubation.]

   Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.

2. Postoperative Pain [15, 30, 45, 60, and 90 minutes after extubation.]

   Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.

3. Total Opioid Consumption [Initial 90 minutes of recover after surgery]

   Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.

Secondary Outcome Measures

1. Heart Rate [15, 30, 45, 60, and 90 minutes after extubation.]

   Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.

2. Modified Short Orientation Memory Concentration Test (SOMCT) [15, 30, 45, 60, and 90 minutes after extubation.]

   The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.

3. Aldrete Score [15, 30, 45, 60, and 90 minutes after extubation.]

   The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.

4. Nursing Workload Comparison [90 minutes after extubation]

   To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).

5. Drug Stop Time to Open Eyes [Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.]

   time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery

6. Drug Stop Time to Recall [Time between extubation until patients could say their names.]

   Time between extubation until patients could say their names.

7. Drug Stop Time to Fitness to Discharge [Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.]

8. End Case to Post Anesthesia Care Unit (PACU) Discharge [End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.]

   Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.

9. Postoperative Nausea [Whether patients had nausea or not, from anesthesia stop time until hospital discharge.]

   Indicator of whether patients had nausea or not

10. Postoperative Vomitting [Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.]

    Indicator of whether patients had postoperative vomiting.

11. Postoperative Shivering [Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.]

    Indicator of whether patients had postoperative shivering.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:

• Age: Older than 18

• Primary and redo cases will be included

• Duration of surgery not exceeding 6 hrs.

Exclusion Criteria:

• Patient refusal

• Emergency craniotomy

• Morbid obesity

• Uncontrolled hypertension - DBP more than 110

• Cardiac conduction defects

• Patients with chronic pain.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
2	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Shobana Rajan, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01269918
• Other Study ID Numbers: 10-1056
• First Posted: Jan 4, 2011
• Last Update Posted: Dec 20, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by The Cleveland Clinic: Craniotomy, pain relief; Adult solid neoplasm
• Additional relevant MeSH terms: Pain, Postoperative; Dexmedetomidine; Remifentanil

Study Results

Participant Flow

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Period Title: Overall Study
STARTED	71	71
COMPLETED	71	68
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Remifentanil	Dexmedetomidine	Total
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.	Total of all reporting groups
Overall Participants	71	68	139
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (14)	56 (14)	56 (14)
Gender (Count of Participants)
Female	37 52.1%	33 48.5%	70 50.4%
Male	34 47.9%	35 51.5%	69 49.6%

Outcome Measures

1. Primary Outcome

Title	Hemodynamics
Description	Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.
Time Frame	15, 30, 45, 60, and 90 minutes after extubation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Mean (Standard Deviation) [mmHg]	98 (11)	88 (12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9
	Confidence Interval	(2-Sided) 95%; -13 to -5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9
	Confidence Interval	(2-Sided) 97.5%; -13 to -4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Postoperative Pain
Description	Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.
Time Frame	15, 30, 45, 60, and 90 minutes after extubation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Mean (Standard Deviation) [units on a scale]	5.1 (2.4)	2.9 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95%; -2.7 to -1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 97.5%; -2.8 to -0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Total Opioid Consumption
Description	Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.
Time Frame	Initial 90 minutes of recover after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Median (Inter-Quartile Range) [mg morphine equivalents]	10	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Noninferiority delta = 2 mg opioid
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-5
	Confidence Interval	(2-Sided) 95%; -10 to -5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-5
	Confidence Interval	(2-Sided) 97.5%; -10 to -3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Heart Rate
Description	Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.
Time Frame	15, 30, 45, 60, and 90 minutes after extubation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Heart rate 15 minutes after extubation	76 (15)	68 (13)
Heart rate 30 minutes after extubation	72 (14)	67 (13)
Heart rate 45 minutes after extubation	73 (14)	66 (13)
Heart rate 60 minutes after extubation	73 (13)	66 (12)
Heart rate 90 minutes after extubation	75 (13)	69 (14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6
	Confidence Interval	(2-Sided) 95%; -10 to 3
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Modified Short Orientation Memory Concentration Test (SOMCT)
Description	The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.
Time Frame	15, 30, 45, 60, and 90 minutes after extubation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
SOMCT 15 minutes after extubation	22 (9)	18 (11)
SOMCT 30 minutes after extubation	25 (7)	20 (11)
SOMCT 45 minutes after extubation	25 (6)	23 (9)
SOMCT 60 minutes after extubation	26 (5)	24 (7)
SOMCT 90 minutes after extubation	26 (5)	25 (7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -2.6 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Aldrete Score
Description	The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.
Time Frame	15, 30, 45, 60, and 90 minutes after extubation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Aldrete score at 15 minutes after extubation	8.4 (1)	8 (1.4)
Aldrete score at 30 minutes after extubation	8.7 (1)	8.3 (1.4)
Aldrete score at 45 minutes after extubation	9.0 (1.0)	8.7 (1.1)
Aldrete score at 60 minutes after extubation	9.2 (0.9)	8.9 (1.1)
Aldrete score at 90 minutes after extubation	9.4 (0.8)	9.1 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Nursing Workload Comparison
Description	To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).
Time Frame	90 minutes after extubation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Median (Inter-Quartile Range) [units on a scale]	6	5.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-1
	Confidence Interval	(2-Sided) 95%; -1 to -0.001
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Drug Stop Time to Open Eyes
Description	time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery
Time Frame	Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Median (Inter-Quartile Range) [minutes]	8	38

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Drug Stop Time to Recall
Description	Time between extubation until patients could say their names.
Time Frame	Time between extubation until patients could say their names.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Median (Inter-Quartile Range) [minutes]	13	42

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Drug Stop Time to Fitness to Discharge
Time Frame	Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Median (Inter-Quartile Range) [minutes]	150	172

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.48 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	End Case to Post Anesthesia Care Unit (PACU) Discharge
Description	Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.
Time Frame	End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	91	68
Median (Inter-Quartile Range) [minutes]	211	215

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Postoperative Nausea
Description	Indicator of whether patients had nausea or not
Time Frame	Whether patients had nausea or not, from anesthesia stop time until hospital discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Number [participants]	12 16.9%	12 17.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.5 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Postoperative Vomitting
Description	Indicator of whether patients had postoperative vomiting.
Time Frame	Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Number [participants]	6 8.5%	2 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.07 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Postoperative Shivering
Description	Indicator of whether patients had postoperative shivering.
Time Frame	Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS	a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Measure Participants	71	68
Number [participants]	7 9.9%	3 4.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Dexmedetomidine
	Comments	Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.1 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Remifentanil		Dexmedetomidine
Arm/Group Description	Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS		a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
All Cause Mortality
	Remifentanil		Dexmedetomidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Remifentanil		Dexmedetomidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	Remifentanil		Dexmedetomidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.