Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Phase 3

Recruiting

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Dexamethasone Oral; Drug: Dexamethasone

• Registration Number: NCT06288035
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-24
• Study First Submitted QC: 2024-02-24
• Study First Posted: 2024-03-01
• Study Start: 2024-03-04
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 814

Inclusion Criteria

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

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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 the postoperative quality of recovery questionnaire
• laparoscopic surgery is converted to open surgery after enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
At-night oral dexamethasone	Dexamethasone Oral	Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.
At-induction dexamethasone	Dexamethasone	Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection.

Primary Outcome Measures

Name	Time	Method
Postoperative nausea or vomiting (PONV)	24 hours after surgery	incidecne of PONV

Secondary Outcome Measures

Name	Time	Method
Rescue antiemetic	24 hours after surgery	need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome)
Early PONV	within 6 hours after surgery	(Dichotomous yes/no outcome)
Visual Analogue Scale (VAS) at the time of discharge from PACU	within 2 hours at the time of discharge from PACU	On VAS scale as numerical outcome
Post-Discharge Nausea and Vomiting (PDNV)	72 hours after surgery.	evaluated by telephone as a binary outcome
Late PONV	6 - 24 hours after surgery	(Dichotomous yes/no outcome)
Postoperative fatigue	after 24 hours at the time of discharge from the hospital	on a 10-point scale
Postoperative quality of recovery	after 24 hours at the time of discharge from the hospital	using the QoR-15 questionnaire
VAS at the time of discharge from hospital	after 24 hours at the time of discharge from the hospital	On VAS scale as numerical outcome

Trial Locations

Locations (1)

Mansoura University Faculty of Medicine; 🇪🇬 Mansoura, Aldakahlia, Egypt