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Trial Outcomes & Findings for Dexmedetomidine to Treat Bariatric Surgery-associated Pain (NCT NCT02880540)

NCT ID: NCT02880540

Last Updated: 2021-12-07

Results Overview

Average pain scores during the day of surgery using the FPS-R rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain. Each level accompanies a facial expression, ranging from content to distress.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

26 participants

Primary outcome timeframe

From surgery until discharge from the hospital, an average of 48 hours.

Results posted on

2021-12-07

Participant Flow

We identified 13 patients who had received dexmedetomidine intraoperatively during the course of laporoscopic sleeve gastrectomy.

Participant milestones

Participant milestones
Measure
Control Group
Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor Fentanyl Morphine
Dexmedetomidine Treated
Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery Dexmedetomidine
Overall Study
STARTED
13
13
Overall Study
COMPLETED
13
13
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine to Treat Bariatric Surgery-associated Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group
n=13 Participants
Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor Fentanyl Morphine
Dexmedetomidine Treated
n=13 Participants
Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery Dexmedetomidine
Total
n=26 Participants
Total of all reporting groups
Age, Categorical
<=18 years
13 Participants
n=93 Participants
13 Participants
n=4 Participants
26 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
16 years
n=93 Participants
18 years
n=4 Participants
17 years
n=27 Participants
Sex: Female, Male
Female
11 Participants
n=93 Participants
8 Participants
n=4 Participants
19 Participants
n=27 Participants
Sex: Female, Male
Male
2 Participants
n=93 Participants
5 Participants
n=4 Participants
7 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=93 Participants
0 Participants
n=4 Participants
7 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=93 Participants
12 Participants
n=4 Participants
18 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Region of Enrollment
United States
13 participants
n=93 Participants
13 participants
n=4 Participants
26 participants
n=27 Participants

PRIMARY outcome

Timeframe: From surgery until discharge from the hospital, an average of 48 hours.

Average pain scores during the day of surgery using the FPS-R rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain. Each level accompanies a facial expression, ranging from content to distress.

Outcome measures

Outcome measures
Measure
Control Group
n=13 Participants
Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor Fentanyl Morphine
Dexmedetomidine Treated
n=13 Participants
Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery Dexmedetomidine
Pain Scores (Numerical Rating Scale 0-10) Using the Faces Pain Scale-Revised
5 Units on a scale
Interval 4.0 to 6.0
3.4 Units on a scale
Interval 3.0 to 4.3

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Dexmedetomidine Treated

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

Janelle Vaughns MD

Children's National Hospital

Phone: 202-476-2025

Results disclosure agreements

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