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Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

Primary Purpose

Obesity, Sleep Apnea, Diabetes

Status
Completed
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Dexmedetomidine
Morphine
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Dexmedetomidine, bariatric surgery, postoperative pain, morphine consumption, Quality of recovery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • American University of Beirut Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine

Morphine

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2014
Last Updated
July 12, 2016
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02213159
Brief Title
Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery
Official Title
Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sleep Apnea, Diabetes, Hypertension
Keywords
Dexmedetomidine, bariatric surgery, postoperative pain, morphine consumption, Quality of recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm 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
Arm Title
Morphine
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
Time Frame
At discharge from the PACU
Secondary Outcome Measure Information:
Title
Time to first morphine requirement in PACU
Time Frame
in the PACU
Title
Numeric Rating Scale (NRS) for Pain
Time Frame
in the PACU and at 24 hours
Title
NRS for nausea
Time Frame
in the PACU
Title
incidence of pruritus
Time Frame
in the PACU
Title
incidence of vomiting or retching
Time Frame
in the PACU
Title
incidence of respiratory complications
Time Frame
in the PACU
Title
time to discharge readiness in PACU
Time Frame
in the PACU
Title
total morphine consumption at 24 hours
Time Frame
at 24 hours
Title
Quality of Recovery (QoR-40) score at 24 hours
Time Frame
at 24 hours
Title
overall satisfaction at one month
Time Frame
one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine Zeeni, M.D.
Organizational Affiliation
AUBMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar Siddik, M.D.
Organizational Affiliation
AUBMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

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