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

NCT06052111 | Completed

• 1 other identifier: 26-2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The time for extubation

  Time from end of anesthesia till safe extubation of the patients

  30 minutes till end of surgery.

Secondary Outcomes (3)

• Mean arterial blood pressure (MAP)

  Intraoperatively.

• Heart rate (HR)

  Intraoperatively

• Incidence of hypotension

  Intraoperatively

Study Arms (2)

Group F (fentanyl group)

EXPERIMENTAL

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.

Drug: Group F (fentanyl group)

Group D (dexmedetomidine group)

EXPERIMENTAL

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.

Drug: Group D (dexmedetomidine group)

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 F (fentanyl group)

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.

Group D (dexmedetomidine group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in Anesthesiology, Intensive care and Pain management, Faculty of Medicine, Helwan University, Qism Helwan Egypt.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: May 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)