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

NCT ID: NCT06052111

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2023-05-15

Brief Summary

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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

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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.

Conditions

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Dexmedetomidine Fentanyl Time to Extubation Morbid Obesity Laparoscopic Sleeve Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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 Type EXPERIMENTAL

Group F (fentanyl group)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

Group D (dexmedetomidine group)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Doha Mohammed Bakr

Assistant lecturer in Anesthesiology, Intensive care and Pain management, Faculty of Medicine, Helwan University, Qism Helwan Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helwan University

Helwan, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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26-2020

Identifier Type: -

Identifier Source: org_study_id

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