Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

Study Overview
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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

Official Title
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Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery

Conditions
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Obesity, Sleep Apnea, Diabetes, Hypertension

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Morphine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>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<br> <br> * Other names: Precedex;|
| Active Comparator: Morphine<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine consumed in Post Anesthesia Care Unit (PACU) |  | At discharge from the PACU | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, bariatric surgery, postoperative pain, morphine consumption, Quality of recovery