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Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02213159
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Sleep Apnea Diabetes Hypertension Drug: Dexmedetomidine Drug: Morphine Phase 2 Phase 3

Detailed Description:
effect of Dexmedetomidine bolus on postoperative morphine requirements

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Dexmedetomidine
Other Name: Precedex

Active Comparator: 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
Drug: Morphine



Primary Outcome Measures :
  1. Total dose of morphine consumed in Post Anesthesia Care Unit (PACU) [ Time Frame: At discharge from the PACU ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213159


Locations
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Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Carine Zeeni, M.D. AUBMC
Principal Investigator: Sahar Siddik, M.D. AUBMC

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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02213159     History of Changes
Other Study ID Numbers: ANES.CZ.2
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by American University of Beirut Medical Center:
Dexmedetomidine
bariatric surgery
postoperative pain
morphine consumption
Quality of recovery
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Dexmedetomidine
Morphine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics