Trial Outcomes & Findings for Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy (NCT NCT03139279)
NCT ID: NCT03139279
Last Updated: 2019-07-29
Results Overview
Each subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
30 minutes
Results posted on
2019-07-29
Participant Flow
We consented 122 patients of which 8 were immediately excluded for the following reasons: procedure began prior to randomization (3), inclusion criteria not met (3), anesthesiologist declined (1), patient withdrew consent (1); 114 were randomized into the treatment and placebo groups.
Participant milestones
| Measure |
Dexmedetomidine and Propofol
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
56
|
|
Overall Study
COMPLETED
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Dexmedetomidine and Propofol
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy
Baseline characteristics by cohort
| Measure |
Dexmedetomidine and Propofol
n=51 Participants
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
n=50 Participants
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Weight
|
77 kilograms
n=5 Participants
|
83.5 kilograms
n=7 Participants
|
80 kilograms
n=5 Participants
|
|
Height
|
65 inches
n=5 Participants
|
65 inches
n=7 Participants
|
65 inches
n=5 Participants
|
|
BMI
|
27.6 kg/m^2
n=5 Participants
|
28.5 kg/m^2
n=7 Participants
|
28.31 kg/m^2
n=5 Participants
|
|
ASA Physical Status Classification System
ASA I: A normal healthy patient
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
ASA Physical Status Classification System
ASA II: A patient with mild systemic disease
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
ASA Physical Status Classification System
ASA III: A patient with severe systemic disease
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
ASA Physical Status Classification System
ASA IV: systemic disease, constant threat to life
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ASA Physical Status Classification System
ASA V: moribund pt, will not survive w/o operation
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ASA Physical Status Classification System
ASA VI: declared brain-dead patient
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
134 mmHg
n=5 Participants
|
140.5 mmHg
n=7 Participants
|
135 mmHg
n=5 Participants
|
|
Diastolic Blood Pressure
|
82 mmHg
n=5 Participants
|
81 mmHg
n=7 Participants
|
81 mmHg
n=5 Participants
|
|
Mean Arterial Pressure
|
99 mmHg
n=5 Participants
|
99 mmHg
n=7 Participants
|
99 mmHg
n=5 Participants
|
|
Heart Rate
|
72 beats per minute
n=5 Participants
|
71 beats per minute
n=7 Participants
|
71 beats per minute
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesEach subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.
Outcome measures
| Measure |
Dexmedetomidine and Propofol
n=51 Participants
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
n=50 Participants
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure
|
26 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: between 7 and 57 minutes (median 19 min)Total propofol consumption per subject was measured as μg/kg/min of procedure in minutes. The average propofol consumption in each group will be measured as secondary outcome.
Outcome measures
| Measure |
Dexmedetomidine and Propofol
n=51 Participants
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
n=50 Participants
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Average Total Propofol Consumption Per Group
|
140 μg/kg/min
Interval 120.0 to 200.0
|
180 μg/kg/min
Interval 130.0 to 240.0
|
SECONDARY outcome
Timeframe: 30 minutesIncidence of sustained bradycardic episodes (HR\<50 for at least 5 minutes) intraoperatively in each group
Outcome measures
| Measure |
Dexmedetomidine and Propofol
n=51 Participants
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
n=50 Participants
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Number of Participants With Sustained Bradycardic Episodes
Sustained bradycardia
|
3 Participants
|
1 Participants
|
|
Number of Participants With Sustained Bradycardic Episodes
No sustained bradycardia
|
48 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 30 minutesLowest intraoperative percent (%) change in mean arterial pressure (MAP) from baseline (average in each group)
Outcome measures
| Measure |
Dexmedetomidine and Propofol
n=51 Participants
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
n=50 Participants
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Lowest Intraoperative % Change in MAP From Baseline
|
30 percentage change
Interval 25.0 to 38.0
|
21 percentage change
Interval 14.0 to 29.0
|
SECONDARY outcome
Timeframe: 30 minutesIncidence of apneic episodes intraoperatively requiring positive pressure ventilation in each group
Outcome measures
| Measure |
Dexmedetomidine and Propofol
n=51 Participants
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Dexmedetomidine: Dexmedetomidine 0.3 ug/kg intravenous bolus
Propofol: Propofol titrated intravenous boluses
|
Saline Placebo and Propofol
n=50 Participants
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
Saline placebo: Intravenous saline/placebo
Propofol: Propofol titrated intravenous boluses
|
|---|---|---|
|
Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation
|
0 Participants
|
0 Participants
|
Adverse Events
Dexmedetomidine and Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Placebo and Propofol
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
Dennis Dimaculangan, MD
Department of Anesthesiology, SUNY Downstate Medical Center
Phone: 718-270-3765
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place