Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT06186895
• Lead Sponsor: Helwan University

Brief Summary

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.

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 Timeline

• Study Start: 2021-07-20
• Primary Completion: 2023-05-20
• Study Completion: 2023-05-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study First Posted: 2024-01-02
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	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
Fentanyl group	Fentanyl	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.

Primary Outcome Measures

Name	Time	Method
visual analogue score	from arrival to PACU until 12 hours after surgery	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

Secondary Outcome Measures

Name	Time	Method
incidence of nausea and vomiting	2 hours after surgery
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

Trial Locations

Locations (1)

Ryad Ghoraba; 🇪🇬 Tanta, Gharbia, Egypt