Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

Phase 2

Completed

• Conditions: Postoperative Nausea and Vomiting; Postoperative Pain; Laparoscopic Cholecystectomy
• Interventions: Drug: At-night Dexamethasone; Drug: At-induction Dexamethasone

• Registration Number: NCT05998317
• Lead Sponsor: Mansoura University

Brief Summary

Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.

A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.

Detailed Description

Background:

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to 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 intravenous (iv) administration.

Methods:

This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (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 IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.

Study Timeline

• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-18
• Study Start: 2023-10-08
• Primary Completion: 2023-11-15
• Study Completion: 2023-11-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• patient refusal
• use of steroids or antiemetic agents within 1 week of surgery
• chronic opioid therapy
• history of allergy to any study medications
• serum creatinine > 1.4 mg/dl
• liver enzymes more than triple normal limits
• pregnancy
• psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire
• Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
postoperative nausea or vomiting (PONV)	24 hours after surgery	incidence of PONV (binary outcome as yes/No)

Secondary Outcome Measures

Name	Time	Method
The need for rescue analgesia	24 hours after surgery	Dichotomous yes/no outcome
Postoperative Care Unit (PACU) and Early PONV	within 6 hours after surgery	Dichotomous yes/no outcome
Late PONV	6-24 hours after surgery	Dichotomous yes/no outcome
Visual Analogue Scale (VAS)	at the time of discharge from hospital (usually 24 hours after surgery)	VAS as a scale 0 - 10
The need for rescue antiemetic	24 hours after surgery	Dichotomous yes/no outcome
Postoperative quality of recovery (QoR)	24 hours after surgery	QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
Post-Discharge Nausea and Vomiting (PDNV)	at 72 hours after surgery	evaluated by telephone by Dichotomous yes/no outcome

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Mansoura, Aldakahlia, Egypt