Clinical trial NCT06288035: Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official title: Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative nausea or vomiting (PONV)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Rescue antiemetic
timeFrame: 24 hours after surgery
measure: Early PONV
timeFrame: within 6 hours after surgery
measure: Late PONV
timeFrame: 6 - 24 hours after surgery
measure: Visual Analogue Scale (VAS) at the time of discharge from PACU
timeFrame: within 2 hours at the time of discharge from PACU
measure: VAS at the time of discharge from hospital
timeFrame: after 24 hours at the time of discharge from the hospital
measure: Postoperative fatigue
timeFrame: after 24 hours at the time of discharge from the hospital
measure: Postoperative quality of recovery
timeFrame: after 24 hours at the time of discharge from the hospital
measure: Post-Discharge Nausea and Vomiting (PDNV)
timeFrame: 72 hours after surgery.
Other outcomes:
measure: Surgical Site Infection (at follow-up)
timeFrame: within 2 weeks - on the follow-up
measure: Itching or burning sensation on dexamethasone injections
timeFrame: during injection of the dexamethoasone
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Faculty of Medicine
state: Aldakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Moataz M Emara, MD, EDAIC
role: PRINCIPAL_INVESTIGATOR
References: