Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

NCT06186895 | Completed

• 1 other identifier: 2-6-2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Dexmedetomidine, fentanyl, analgesia,Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Fentanyl group

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine group

Fentanyl DRUG

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.

Fentanyl group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Ryad Ghoraba

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthessiology, surgical intensive care and pain medicine

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: July 20, 2021
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publishing

Locations

EG (1)