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Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

A

American University of Beirut Medical Center

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hypertension
Diabetes
Obesity
Sleep Apnea

Treatments

Drug: Morphine
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02213159
ANES.CZ.2

Details and patient eligibility

About

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.

Full description

effect of Dexmedetomidine bolus on postoperative morphine requirements

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Dexmedetomidine
Active Comparator group
Description:
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
Treatment:
Drug: Dexmedetomidine
Morphine
Active Comparator group
Description:
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
Treatment:
Drug: Morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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