Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

Phase 2

Completed

• Conditions: Obesity; Sleep Apnea; Hypertension; Diabetes
• Interventions: Drug: Dexmedetomidine; Drug: Morphine

• Registration Number: NCT02213159
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.

Detailed Description

effect of Dexmedetomidine bolus on postoperative morphine requirements

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-11
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Body Mass Index > 40 kg/m2 or BMI > 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea
• American Society of Anesthesiologists class I or II
• Undergoing laparoscopic sleeve gastrectomy bariatric surgery

Exclusion Criteria

• Allergy to morphine or its derivatives
• Allergy to α-2 adrenergic agonists
• weight over 180 kg
• history of uncontrolled hypertension
• heart block greater than first degree
• prolonged QT interval
• clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases
• received an opioid analgesic medication within a 24 h period prior to surgery
• history of alcohol, drug abuse or chronic opioid intake
• history of psychiatric disorder
• pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes
Morphine	Morphine	prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes

Primary Outcome Measures

Name	Time	Method
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)	At discharge from the PACU

Secondary Outcome Measures

Name	Time	Method
Time to first morphine requirement in PACU	in the PACU
Numeric Rating Scale (NRS) for Pain	in the PACU and at 24 hours
NRS for nausea	in the PACU
incidence of pruritus	in the PACU
incidence of vomiting or retching	in the PACU
incidence of respiratory complications	in the PACU
time to discharge readiness in PACU	in the PACU
total morphine consumption at 24 hours	at 24 hours
Quality of Recovery (QoR-40) score at 24 hours	at 24 hours
overall satisfaction at one month	one month after surgery

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon