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

Sponsor
Helwan University (Other)
Overall Status
Completed
CT.gov ID
NCT06052111
Collaborator
(none)
64
1
2
24
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Group F (fentanyl group)
  • Drug: Group D (dexmedetomidine group)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial
Actual Study Start Date :
May 15, 2021
Actual Primary Completion Date :
May 15, 2023
Actual Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Group F (fentanyl group)
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.

Experimental: 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.

Drug: Group D (dexmedetomidine group)
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.

Outcome Measures

Primary Outcome Measures

  1. The time for extubation [30 minutes till end of surgery.]

    Time from end of anesthesia till safe extubation of the patients

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helwan University Helwan Cairo Egypt

Sponsors and Collaborators

  • Helwan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Doha Mohammed Bakr, Assistant lecturer in Anesthesiology, Intensive care and Pain management, Faculty of Medicine, Helwan University, Qism Helwan Egypt., Helwan University
ClinicalTrials.gov Identifier:
NCT06052111
Other Study ID Numbers:
  • 26-2020
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023