Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Dexamethasone Oral; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Estimated): 814
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Moataz M Emara, MD, EDAIC; Phone Number: +201064048848; Email: mm.emara@mans.edu.eg

Study Locations

• Egypt
  • Aldakahlia
    • Mansoura, Aldakahlia, Egypt, 35516
      • Recruiting
      • Mansoura University Faculty of Medicine
      • Contact: Moataz M Emara, MD, EDAIC; Phone Number: 01064048848; Email: mm.emara@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea or vomiting (PONV)	incidecne of PONV	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue antiemetic	need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome)	24 hours after surgery
Early PONV	(Dichotomous yes/no outcome)	within 6 hours after surgery
Late PONV	(Dichotomous yes/no outcome)	6 - 24 hours after surgery
Visual Analogue Scale (VAS) at the time of discharge from PACU	On VAS scale as numerical outcome	within 2 hours at the time of discharge from PACU
VAS at the time of discharge from hospital	On VAS scale as numerical outcome	after 24 hours at the time of discharge from the hospital
Postoperative fatigue	on a 10-point scale	after 24 hours at the time of discharge from the hospital
Postoperative quality of recovery	using the QoR-15 questionnaire	after 24 hours at the time of discharge from the hospital
Post-Discharge Nausea and Vomiting (PDNV)	evaluated by telephone as a binary outcome	72 hours after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection (at follow-up)	as evaluated by the surgeon	within 2 weeks - on the follow-up
Itching or burning sensation on dexamethasone injections	Dichotomous yes/no outcome	during injection of the dexamethoasone

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Moataz M Emara, MD, EDAIC, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: February 24, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: R.21.02.1191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available with the principal investigator on a reasonable request after approval of the local IRB.
• IPD Sharing Time Frame: Within one year after the completion of the study
• IPD Sharing Access Criteria: Will be reported after completion of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No