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.

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.

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

Data will be available with the principal investigator on a reasonable request after approval of the local IRB.

Within one year after the completion of the study

Will be reported after completion of the study.

The outcome assessors will be blinded to the group allocation.