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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06052111
• Other study ID #: 26-2020
• Status: Completed
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: September 2023
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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 a2 -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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Fentanyl
• Laparoscopic Sleeve Gastrectomy
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Helwan University	Helwan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time for extubation	Time from end of anesthesia till safe extubation of the patients	30 minutes till end of surgery.
Secondary	Mean arterial blood pressure (MAP)	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.	Intraoperatively.
Secondary	Heart rate (HR)	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.	Intraoperatively
Secondary	Incidence of hypotension	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.	Intraoperatively