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

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ClinicalTrials.gov Identifier: NCT06052111
Recruitment Status : Completed
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Doha Mohammed Bakr, Helwan University

Study Description
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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
Dexmedetomidine Fentanyl Time to Extubation Morbid Obesity Laparoscopic Sleeve Gastrectomy Drug: Group F (fentanyl group) Drug: Group D (dexmedetomidine group) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. The time for extubation [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052111


Locations
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Egypt
Helwan University
Helwan, Cairo, Egypt
Sponsors and Collaborators
Helwan University
More Information
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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: September 25, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Fentanyl
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics