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Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

H

Helwan University

Status

Completed

Conditions

Pain, Postoperative

Treatments

Drug: Dexmedetomidine
Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT06186895
2-6-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Dexmedetomidine group
Experimental group
Description:
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
Treatment:
Drug: Dexmedetomidine
Fentanyl group
Active Comparator group
Description:
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.
Treatment:
Drug: Fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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