Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery

Obesity Clinical Trial

Official title:

Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213159
• Other study ID #: ANES.CZ.2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 8, 2014
• Last updated: July 12, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

effect of Dexmedetomidine bolus on postoperative morphine requirements

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity
• Sleep Apnea

Intervention

Drug:
• Dexmedetomidine

• Morphine

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)		At discharge from the PACU	No
Secondary	Time to first morphine requirement in PACU		in the PACU	No
Secondary	Numeric Rating Scale (NRS) for Pain		in the PACU and at 24 hours	No
Secondary	NRS for nausea		in the PACU	No
Secondary	incidence of pruritus		in the PACU	No
Secondary	incidence of vomiting or retching		in the PACU	No
Secondary	incidence of respiratory complications		in the PACU	Yes
Secondary	time to discharge readiness in PACU		in the PACU	No
Secondary	total morphine consumption at 24 hours		at 24 hours	No
Secondary	Quality of Recovery (QoR-40) score at 24 hours		at 24 hours	No
Secondary	overall satisfaction at one month		one month after surgery	No