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NCT Number: NCT06052111

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

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

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Key information

Conditions

Dexmedetomidine Body Weight Fentanyl Laparoscopic Sleeve Gastrectomy Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Time to Extubation

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University

Helwan, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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