Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

NCT ID: NCT02213159

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

Brief Summary

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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

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effect of Dexmedetomidine bolus on postoperative morphine requirements

Conditions

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Obesity Sleep Apnea Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Morphine

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carine Zeeni, M.D.

Role: PRINCIPAL_INVESTIGATOR

AUBMC

Sahar Siddik, M.D.

Role: PRINCIPAL_INVESTIGATOR

AUBMC

Locations

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American University of Beirut Medical Center

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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ANES.CZ.2

Identifier Type: -

Identifier Source: org_study_id

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