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

Helwan University64 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dexmedetomidine Fentanyl Time to Extubation Morbid Obesity Laparoscopic Sleeve Gastrectomy

Interventions

Group F (fentanyl group)DRUG

Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation and was stopped 10 minutes before the end of surgery.

Group D (dexmedetomidine group)DRUG

The patients received loading dose of dexmedetomidine (1 μg/kg) (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) 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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Helwan University

Helwan, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

The time for extubation

Time from end of anesthesia till safe extubation of the patients

Time frame: 30 minutes till end of surgery.

Secondary Outcomes

Mean arterial blood pressure (MAP)

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.

Time frame: Intraoperatively.

Heart rate (HR)

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.

Time frame: Intraoperatively

Incidence of hypotension

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.

Time frame: Intraoperatively

Data from ClinicalTrials.gov

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