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Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06186895
Enrollment
64
Registered
2024-01-02
Start date
2021-07-20
Completion date
2023-05-20
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Dexmedetomidine, fentanyl, analgesia,Sleeve Gastrectomy

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.

Interventions

DRUGDexmedetomidine

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.

DRUGFentanyl

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.

Sponsors

Helwan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scorefrom arrival to PACU until 12 hours after surgeryvisual 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

MeasureTime frame
The time of the first analgesic requestfirst postoperative day
the total opioid dose consumed during the first 12 hours postoperatively12 hours after surgery
incidence of nausea and vomiting2 hours after surgery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026