Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT ID: NCT06288035

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 814 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-03-31

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

At-night oral dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone Oral

Intervention Type: DRUG

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

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 sensations in injection.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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.

Interventions

Dexamethasone Oral

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

Intervention Type: DRUG

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 sensations in injection.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moataz M Emara, MD, EDAIC

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Mansoura University Faculty of Medicine

Al Mansurah, Aldakahlia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Moataz M Emara, MD, EDAIC

Role: CONTACT

mm.emara@mans.edu.eg

+201064048848

Facility Contacts

Moataz M Emara, MD, EDAIC

Role: primary

mm.emara@mans.edu.eg

01064048848

Other Identifiers

R.21.02.1191

Identifier Type: -

Identifier Source: org_study_id