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Completed

NCT Number: NCT06186895

Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in 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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryad Ghoraba

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. visual analogue score

    Time frame: 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 outcomes

  1. The time of the first analgesic request

    Time frame: first postoperative day

  2. the total opioid dose consumed during the first 12 hours postoperatively

    Time frame: 12 hours after surgery

  3. incidence of nausea and vomiting

    Time frame: 2 hours after surgery

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2024
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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