Trial Outcomes & Findings for Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery (NCT NCT01337739)
NCT ID: NCT01337739
Last Updated: 2013-07-12
Results Overview
The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.
TERMINATED
NA
8 participants
Interoperative period
2013-07-12
Participant Flow
Subjects were introduced to the study in a clinic setting and allowed to review the consent prior to their operative procedure.
10 subjects were approached and all of the subjects agreed to participate.
Participant milestones
| Measure |
Placebo Comparator
Continuous infusion of placebo during operative procedure
|
Active Comparator
Administration of Dexmedetomidine
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery
Baseline characteristics by cohort
| Measure |
Placebo Comparator
n=6 Participants
Continuous infusion of placebo during operative procedure
|
Active Comparator
n=4 Participants
Administration of Dexmedetomidine
|
Total
n=10 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
43.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 7.43 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Interoperative periodThe primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.
Outcome measures
| Measure |
Placebo Comparator
n=6 Participants
Continuous infusion of placebo during operative procedure
|
Active Comparator
n=4 Participants
Administration of Dexmedetomidine
|
|---|---|---|
|
The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.
|
11.8 Total Morphine Equivalents mg
Standard Deviation 3.5
|
11.58 Total Morphine Equivalents mg
Standard Deviation 4.79
|
SECONDARY outcome
Timeframe: 24 HoursTime to discharge from the Post Anesthesia Care Unit or home or to hospital room.
Outcome measures
| Measure |
Placebo Comparator
n=6 Participants
Continuous infusion of placebo during operative procedure
|
Active Comparator
n=4 Participants
Administration of Dexmedetomidine
|
|---|---|---|
|
Time to Discharge
|
88.16 minutes
Standard Deviation 30
|
115 minutes
Standard Deviation 33.7
|
Adverse Events
Placebo Comparator
Active Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place