Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Last updated: March 8, 2024
Sponsor: Mansoura University
Overall Status: Active - Recruiting

Phase

3

Condition

Vomiting

Colic

Stomach Discomfort

Treatment

Dexamethasone

Dexamethasone Oral

Clinical Study ID

NCT06288035
R.21.02.1191
  • Ages > 18
  • All Genders

Study Summary

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • all consecutive adults (older than 18 years) with ASA physical status I-III undergoingelective laparoscopic cholecystectomy surgery.

Exclusion

Exclusion Criteria:

  • steroids or antiemetics within 1 week of surgery
  • chronic opioid therapy
  • history of allergy to any of the study drug
  • serum creatinine > 1.4 mg/dl
  • liver enzymes > triple the normal limits
  • pregnancy
  • patient refusal
  • and psychiatric or neurologic diseases or socioeconomic status that would hinder thepostoperative quality of recovery questionnaire
  • laparoscopic surgery is converted to open surgery after enrollment

Study Design

Total Participants: 814
Treatment Group(s): 2
Primary Treatment: Dexamethasone
Phase: 3
Study Start date:
March 04, 2024
Estimated Completion Date:
March 31, 2025

Study Description

Background:

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.

Methods:

This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.

Discussion:

The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.

Connect with a study center

  • Mansoura University Faculty of Medicine

    Mansoura, Aldakahlia 35516
    Egypt

    Active - Recruiting

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