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Completed

NCT Number: NCT02213159

Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

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.

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Key information

Conditions

Obesity Apnea Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

effect of Dexmedetomidine bolus on postoperative morphine requirements

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

Other names: Precedex

Morphine

Drug

Primary outcomes

  1. Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)

    Time frame: At discharge from the PACU

Secondary outcomes

  1. Time to first morphine requirement in PACU

    Time frame: in the PACU

  2. Numeric Rating Scale (NRS) for Pain

    Time frame: in the PACU and at 24 hours

  3. NRS for nausea

    Time frame: in the PACU

  4. incidence of pruritus

    Time frame: in the PACU

  5. incidence of vomiting or retching

    Time frame: in the PACU

  6. incidence of respiratory complications

    Time frame: in the PACU

  7. time to discharge readiness in PACU

    Time frame: in the PACU

  8. total morphine consumption at 24 hours

    Time frame: at 24 hours

  9. Quality of Recovery (QoR-40) score at 24 hours

    Time frame: at 24 hours

  10. overall satisfaction at one month

    Time frame: one month after surgery

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2014
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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