Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06186895
• Other study ID #: 2-6-2020
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: May 20, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

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

Eligibility

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 a2 -adrenergic agonist.
• kidney, liver, neuromuscular disorders, and cardiac disease.
• or patients on opioid medications.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ryad Ghoraba	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The time of the first analgesic request		first postoperative day
Secondary	the total opioid dose consumed during the first 12 hours postoperatively		12 hours after surgery
Secondary	incidence of nausea and vomiting		2 hours after surgery