Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Mansoura University

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Dexamethasone; Drug: Dexamethasone Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT06288035

R.21.02.1191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 814 estimated 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.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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814 participants in 2 patient groups

At-night oral dexamethasone

Experimental group

Description:

Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.

Treatment:

Drug: Dexamethasone Oral

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 sensations in injection.

Treatment:

Drug: Dexamethasone