Trial Outcomes & Findings for Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients (NCT NCT02604940)

NCT ID: NCT02604940

Last Updated: 2024-01-17

Results Overview

Amount of narcotic delivered to patient by Patient Controlled Analgesia (PCA)Pump in milligrams at 240 minutes

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: At 240 minutes after arriving in Post Anesthesia care Unit
• Results posted on: 2024-01-17

Participant Flow

Participant milestones

Measure	Dexmedetomidine Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Overall Study STARTED	26	20
Overall Study COMPLETED	26	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.	Total n=46 Participants Total of all reporting groups
Age, Continuous	45.1 years n=26 Participants	43.2 years n=20 Participants	44.3 years n=46 Participants
Sex: Female, Male Female	21 Participants n=26 Participants	16 Participants n=20 Participants	37 Participants n=46 Participants
Sex: Female, Male Male	5 Participants n=26 Participants	4 Participants n=20 Participants	9 Participants n=46 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index	46.0 kg/m^2 n=26 Participants	45.63 kg/m^2 n=20 Participants	45.89 kg/m^2 n=46 Participants

PRIMARY outcome

Timeframe: At 240 minutes after arriving in Post Anesthesia care Unit

Amount of narcotic delivered to patient by Patient Controlled Analgesia (PCA)Pump in milligrams at 240 minutes

Outcome measures

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes	2.66 mg Standard Deviation 2.02	3.7 mg Standard Deviation 2.3

SECONDARY outcome

Timeframe: At 240 minutes after arriving in Post Anesthesia care Unit

Pain scores on a scale of 1-10 measured in the post anesthesia care unit at 240 minutes

Outcome measures

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Pain Score on a Scale of 1-10 (1=Least 10= Worst)	3.6 score on a scale Standard Deviation 2.8	6.7 score on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: At 240 minutes after arriving in Post Anesthesia care Unit

Heart Rate as recorded in the Medical record at 240 Minutes

Outcome measures

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Heart Rate - Per Minute	70 beats per minute Standard Deviation 12	86 beats per minute Standard Deviation 14

SECONDARY outcome

Timeframe: At 240 minutes after arriving in Post Anesthesia care Unit

Blood Pressure as recorded in the Medical record at 240 Minutes

Outcome measures

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Blood Pressure - Measured in mmHg Systolic BP	107 mmHg Standard Deviation 17	148 mmHg Standard Deviation 16
Blood Pressure - Measured in mmHg Diastolic BP	56 mmHg Standard Deviation 15	79 mmHg Standard Deviation 13

SECONDARY outcome

Timeframe: At 240 minutes after arriving in Post Anesthesia care Unit

Oxygen Saturation as recorded in the medical record at 240 minutes

Outcome measures

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Oxygen Saturation - Measured in Percentage	97 percentage of oxygen saturation Standard Deviation 2	99 percentage of oxygen saturation Standard Deviation 2

SECONDARY outcome

Timeframe: At 240 minutes after arriving in Post Anesthesia care Unit

Breaths per minute as recorded in the medical record at 240 minutes

Outcome measures

Measure	Dexmedetomidine n=26 Participants Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure	Normal Saline n=20 Participants Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Respiratory Rate as Measured Per Minute	17 Breaths per minute Standard Deviation 4	17 Breaths per minute Standard Deviation 3

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

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

Pavithra Ranganathan Ellison, MD

West Virginia University

Phone: 304-598-4929

Email: pavithra.ellison@wvumedicine.org

Results disclosure agreements

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