Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

Mansoura University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain; Laparoscopic Cholecystectomy; Postoperative Nausea and Vomiting

Treatments: Drug: At-induction Dexamethasone; Drug: At-night Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05998317

R.23.07.2239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

At-night dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: At-night Dexamethasone

At-induction dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: At-induction Dexamethasone