Trial Outcomes & Findings for Dexmedetomidine Versus Propofol in Vitreoretinal Surgery (NCT NCT01001429)

NCT ID: NCT01001429

Last Updated: 2017-08-21

Results Overview

Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 78 participants
• Primary outcome timeframe: Intraoperative up to 120 min
• Results posted on: 2017-08-21

Participant Flow

Subjects were recruited the morning of surgery in the Same Day Surgery Suite

One subject withdrew consent prior to group assignment. One subject surgery was cancelled

Participant milestones

Measure	Propofol propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	Dexmedetomidine Infusion Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug
Overall Study STARTED	39	38
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Propofol propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	Dexmedetomidine Infusion Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug
Overall Study surgery cancelled	0	1

Baseline Characteristics

Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

Baseline characteristics by cohort

Measure	Propofol n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	Dexmedetomidine Infusion n=37 Participants Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	Total n=76 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	52 years n=7 Participants	46 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
total participants	39 participants n=5 Participants	37 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative up to 120 min

Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group n=39 Participants Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group n=37 Participants subject received medication as described in BIS/dexmedetomidine
Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)	84.8 units on a scale Interval 77.5 to 92.1	88 units on a scale Interval 78.0 to 94.0	.90 units on a scale Interval 0.47 to 1.33	.94 units on a scale Interval 0.43 to 1.45

PRIMARY outcome

Timeframe: Intraoperative up to 120 min

systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group n=39 Participants Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group n=37 Participants subject received medication as described in BIS/dexmedetomidine
Intraoperative Hemodynamic Stability	124.9 mm/Hg Interval 108.7 to 141.1	114.6 mm/Hg Interval 100.1 to 129.1	73.6 mm/Hg Interval 61.1 to 86.1	66.2 mm/Hg Interval 55.4 to 77.0

PRIMARY outcome

Timeframe: Intraoperative up to 120 min

respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Intraoperative Respiratory Stability	17 breaths per minute Interval 12.0 to 22.0	12 breaths per minute Interval 8.0 to 16.0	—	—

PRIMARY outcome

Timeframe: Intraoperative up to 120 min

Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Intraoperative Heart Rate Stability	71 beats per minute Interval 58.0 to 84.0	64 beats per minute Interval 49.0 to 80.0	—	—

SECONDARY outcome

Timeframe: for 2 hours post-operatively in Post Anesthesia Care unit

Population: Subjects meet criteria for discharge based upon the assessment from a professional independent of the study

Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Time to Achieve "Street Fitness"	81 minutes Interval 54.0 to 108.0	85 minutes Interval 49.8 to 120.0	—	—

SECONDARY outcome

Timeframe: at 10 minutes into the procedure

1=very poor, 2=poor,3=fair, 4=good, 5=excellent

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Surgeon Satisfaction for Adequate Sedation	4.62 units on a scale Interval 3.0 to 5.0	4.97 units on a scale Interval 3.0 to 5.0	—	—

SECONDARY outcome

Timeframe: immediately following the completion of the procedure up to one hour

surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Surgeon Satisfaction for Adequate Sedation at Completion of Procedure	4.77 units on a scale Interval 3.0 to 5.0	4.89 units on a scale Interval 3.0 to 5.0	—	—

SECONDARY outcome

Timeframe: measured prior to discharge up to 2 hours

1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Patient Satisfaction	4.61 units on a scale Interval 3.0 to 5.0	4.43 units on a scale Interval 3.0 to 5.0	—	—

SECONDARY outcome

Timeframe: 2 hours in PACU

blood pressure documented at 30 minute intervals in PACU up to 120 min

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group n=39 Participants Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group n=37 Participants subject received medication as described in BIS/dexmedetomidine
Post Operative Hemodynamic Stability	124.9 mmHg Interval 108.7 to 141.1	114.6 mmHg Interval 100.1 to 129.1	73.6 mmHg Interval 61.1 to 86.1	66.2 mmHg Interval 55.4 to 77.0

SECONDARY outcome

Timeframe: PACU to 2 hours post op

heart rate recorded at 30 min intervals in PACU up to 120 min

Outcome measures

Measure	BIS Scores in Propofol Infusion Group n=39 Participants propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	BIS Scores in Dexmedetomidine Infusion Group n=37 Participants Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug	UMSS Scores in Propofol Infusion Group Propofol medication administered as described in BIS group/Propofol group	UMSS in Dexmedetomidine Infusion Group subject received medication as described in BIS/dexmedetomidine
Hemodynamic Stability Post Operatively in PACU	74.1 beats per minute Interval 72.0 to 77.0	72 beats per minute Interval 71.0 to 73.0	—	—

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine Infusion

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Propofol n=39 participants at risk propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min	Dexmedetomidine Infusion n=37 participants at risk Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug
Cardiac disorders T wave inversion on EKG	0.00% 0/39 • Heart rate, blood pressure, pulse oximetry are collected for all patients undergoing sedation or anesthesia for the entire time they are in the operating room which was between 1-2 hrs. Additionally heart rate, blood pressure, pulse oximetry were monitored for 2 hours in the Post Anesthesia Care Unit where patients are placed immediately following the procedure. Change in ECG, T wave inversion was noted on the cardiac monitor in the operating room, no intervention was required and the surgery continued without incident. A cardiology consult was called and the subject was admitted for observation. A myocardial perfusion test demonstrated a fixed deficit in the left ventricle, the Ejection fraction was 55% and serial Troponin levels were\<0.2, well below threshold for evidence of myocardial injury	2.7% 1/37 • Number of events 1 • Heart rate, blood pressure, pulse oximetry are collected for all patients undergoing sedation or anesthesia for the entire time they are in the operating room which was between 1-2 hrs. Additionally heart rate, blood pressure, pulse oximetry were monitored for 2 hours in the Post Anesthesia Care Unit where patients are placed immediately following the procedure. Change in ECG, T wave inversion was noted on the cardiac monitor in the operating room, no intervention was required and the surgery continued without incident. A cardiology consult was called and the subject was admitted for observation. A myocardial perfusion test demonstrated a fixed deficit in the left ventricle, the Ejection fraction was 55% and serial Troponin levels were\<0.2, well below threshold for evidence of myocardial injury

Other adverse events

Adverse event data not reported

Additional Information

Anuradha Patel, MD

Rutgers New Jersey Medical School

Phone: 973 972-1886

Email: patelan@njms.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place