Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy

Dexmedetomidine (Dex) activates the α2 adrenergic receptor that is present within the locus coeruleus, leading to anxiolysis, hypnosis, analgesia, and sedation.

We conducted our research to compare the effects of fentanyl and DEX on the postoperative analgesic profile and complications in morbidly obese patients after sleeve gastrectomy.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Fentanyl

Detailed Description

The participants were assigned to two groups of equal size (32 patients in each group) by the use of computer-generated numbers and sealed opaque envelopes. The participants allocated to the DEX group, also known as Group D, received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal. The patients assigned to the fentanyl group (referred to as Group F) were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Ryad Ghoraba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• body mass index (BMI) of 35 kg/m2 or more.
• American Society of Anesthesiology (ASA) physical status of II-III.
• all participants would have a laparoscopic sleeve gastrectomy (LSG).

Exclusion Criteria:

• allergy to α2 -adrenergic agonist.
• kidney, liver, neuromuscular disorders, and cardiac disease.
• or patients on opioid medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; Group D, received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal	Drug: Dexmedetomidine; received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal.
Active Comparator: Fentanyl group; Group F were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.	Drug: Fentanyl; fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue score	visual analogue pain score (VAS) from 0-10 (0: no pain, 10: the worst pain). It was assessed in post anesthesia care unit ( PACU) and every 2 hours for 12 hours postoperatively	from arrival to PACU until 12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
The time of the first analgesic request	first postoperative day
the total opioid dose consumed during the first 12 hours postoperatively	12 hours after surgery
incidence of nausea and vomiting	2 hours after surgery

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Estimated): January 1, 2024

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine, fentanyl, analgesia,Sleeve Gastrectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: 2-6-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after publishing, the information will be accessible on demand
• IPD Sharing Time Frame: after publishing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No