Trial Outcomes & Findings for A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (NCT NCT01269918)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

142 participants

Primary outcome timeframe

15, 30, 45, 60, and 90 minutes after extubation.

Results posted on

2016-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Remifentanil 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	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. 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.
Overall Study STARTED	71	71
Overall Study COMPLETED	71	68
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Remifentanil 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	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. 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.
Overall Study Did not receive study drug	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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 n=139 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants	56 years STANDARD_DEVIATION 14 • n=7 Participants	56 years STANDARD_DEVIATION 14 • n=5 Participants
Gender Female	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Gender Male	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Hemodynamics	98 mmHg Standard Deviation 11	88 mmHg Standard Deviation 12

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Postoperative Pain	5.1 units on a scale Standard Deviation 2.4	2.9 units on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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 Opioid Consumption	10 mg morphine equivalents Interval 7.0 to 15.0	5 mg morphine equivalents Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Heart Rate Heart rate 60 minutes after extubation	73 beats per minute Standard Deviation 13	66 beats per minute Standard Deviation 12
Heart Rate Heart rate 15 minutes after extubation	76 beats per minute Standard Deviation 15	68 beats per minute Standard Deviation 13
Heart Rate Heart rate 30 minutes after extubation	72 beats per minute Standard Deviation 14	67 beats per minute Standard Deviation 13
Heart Rate Heart rate 45 minutes after extubation	73 beats per minute Standard Deviation 14	66 beats per minute Standard Deviation 13
Heart Rate Heart rate 90 minutes after extubation	75 beats per minute Standard Deviation 13	69 beats per minute Standard Deviation 14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Modified Short Orientation Memory Concentration Test (SOMCT) SOMCT 15 minutes after extubation	22 units on a scale Standard Deviation 9	18 units on a scale Standard Deviation 11
Modified Short Orientation Memory Concentration Test (SOMCT) SOMCT 30 minutes after extubation	25 units on a scale Standard Deviation 7	20 units on a scale Standard Deviation 11
Modified Short Orientation Memory Concentration Test (SOMCT) SOMCT 45 minutes after extubation	25 units on a scale Standard Deviation 6	23 units on a scale Standard Deviation 9
Modified Short Orientation Memory Concentration Test (SOMCT) SOMCT 60 minutes after extubation	26 units on a scale Standard Deviation 5	24 units on a scale Standard Deviation 7
Modified Short Orientation Memory Concentration Test (SOMCT) SOMCT 90 minutes after extubation	26 units on a scale Standard Deviation 5	25 units on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Aldrete Score Aldrete score at 15 minutes after extubation	8.4 units on a scale Standard Deviation 1	8 units on a scale Standard Deviation 1.4
Aldrete Score Aldrete score at 30 minutes after extubation	8.7 units on a scale Standard Deviation 1	8.3 units on a scale Standard Deviation 1.4
Aldrete Score Aldrete score at 45 minutes after extubation	9.0 units on a scale Standard Deviation 1.0	8.7 units on a scale Standard Deviation 1.1
Aldrete Score Aldrete score at 60 minutes after extubation	9.2 units on a scale Standard Deviation 0.9	8.9 units on a scale Standard Deviation 1.1
Aldrete Score Aldrete score at 90 minutes after extubation	9.4 units on a scale Standard Deviation 0.8	9.1 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Nursing Workload Comparison	6 units on a scale Interval 6.0 to 8.0	5.5 units on a scale Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Drug Stop Time to Open Eyes	8 minutes Interval 7.0 to 9.0	38 minutes Interval 29.0 to 44.0

SECONDARY outcome

Timeframe: Time between extubation until patients could say their names.

Time between extubation until patients could say their names.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Drug Stop Time to Recall	13 minutes Interval 10.0 to 15.0	42 minutes Interval 36.0 to 49.0

SECONDARY outcome

Timeframe: 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 measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Drug Stop Time to Fitness to Discharge	150 minutes Interval 117.0 to 175.0	172 minutes Interval 160.0 to 206.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remifentanil n=91 Participants 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	Dexmedetomidine n=68 Participants 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.
End Case to Post Anesthesia Care Unit (PACU) Discharge	211 minutes Interval 183.0 to 228.0	215 minutes Interval 184.0 to 236.0

SECONDARY outcome

Timeframe: Whether patients had nausea or not, from anesthesia stop time until hospital discharge.

Indicator of whether patients had nausea or not

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Postoperative Nausea	12 participants	12 participants

SECONDARY outcome

Timeframe: Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.

Indicator of whether patients had postoperative vomiting.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Postoperative Vomitting	6 participants	2 participants

SECONDARY outcome

Timeframe: Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.

Indicator of whether patients had postoperative shivering.

Outcome measures

Outcome measures
Measure	Remifentanil n=71 Participants 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	Dexmedetomidine n=68 Participants 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.
Postoperative Shivering	7 participants	3 participants

Adverse Events

Remifentanil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Sessler, MD

Cleveland Clinic

Phone: 216-445-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place