Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Dexmedetomidine; Fentanyl; Morbid Obesity; Time to Extubation; Laparoscopic Sleeve Gastrectomy
• Interventions: Drug: Group F (fentanyl group); Drug: Group D (dexmedetomidine group)

• Registration Number: NCT06052111
• Lead Sponsor: Helwan University

Brief Summary

This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.

Detailed Description

The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.

Study Timeline

• Study Start: 2021-05-15
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-25
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age from 20 to 50 years old.
• Both sexes.
• American Standards Association (ASA) physical status II - III.
• Body Mass Index (BMI) ≥ 35 kg/m2.

Exclusion Criteria

• Allergy to α2 -adrenergic agonist.
• History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
• Neuromuscular disease, liver disease (coagulopathy INR>1.5 or platelet count <100.000/μl), renal impairment (serum creatinine >1.2mg/dl, serum K >5.5mmol/l).
• Opioid medication within 24 hours before the operation.
• Respiratory diseases as COPD, uncontrolled asthmatic patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F (fentanyl group)	Group F (fentanyl group)	Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation. It was stopped 10 minutes before the end of surgery.
Group D (dexmedetomidine group)	Group D (dexmedetomidine group)	The patients were received a loading dose of dexmedetomidine (1 μg/kg) intravenously over 15 minutes before induction of anesthesia, followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.

Primary Outcome Measures

Name	Time	Method
The time for extubation	30 minutes till end of surgery.	Time from end of anesthesia till safe extubation of the patients

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure (MAP)	Intraoperatively.	Mean arterial blood pressure will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Heart rate (HR)	Intraoperatively	Heart rate will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Incidence of hypotension	Intraoperatively	Mean arterial blood pressure (MAP)\<60mmHg. Ephedrine (5 mg) and 250 ml fluid bolus will be given if MAP \< 60 mmHg or decrease 20% of the baseline value.

Trial Locations

Locations (1)

Helwan University; 🇪🇬 Helwan, Cairo, Egypt