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

Helwan University

Status: Completed

Conditions: Time to Extubation; Laparoscopic Sleeve Gastrectomy; Fentanyl; Dexmedetomidine; Morbid Obesity

Treatments: Drug: Group D (dexmedetomidine group); Drug: Group F (fentanyl group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06052111

26-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Group F (fentanyl group)

Experimental group

Description:

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.

Treatment:

Drug: Group F (fentanyl group)

Group D (dexmedetomidine group)

Experimental group

Description:

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.

Treatment:

Drug: Group D (dexmedetomidine group)