Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT06288035 | Recruiting Phase 3 DMC

• 1 other identifier: R.21.02.1191
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea or vomiting (PONV)

  incidecne of PONV

  24 hours after surgery

Secondary Outcomes (8)

• Rescue antiemetic

  24 hours after surgery

• Early PONV

  within 6 hours after surgery

• Late PONV

  6 - 24 hours after surgery

• Visual Analogue Scale (VAS) at the time of discharge from PACU

  within 2 hours at the time of discharge from PACU

• VAS at the time of discharge from hospital

  after 24 hours at the time of discharge from the hospital

Other Outcomes (2)

• Surgical Site Infection (at follow-up)

  within 2 weeks - on the follow-up

• Itching or burning sensation on dexamethasone injections

  during injection of the dexamethoasone

Study Arms (2)

At-night oral dexamethasone

EXPERIMENTAL

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

At-induction dexamethasone

ACTIVE COMPARATOR

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

Interventions

Dexamethasone Oral 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-night oral dexamethasone

Dexamethasone 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.

At-induction dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Faculty of Medicine

Al Mansurah, Aldakahlia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Moataz M Emara, MD, EDAIC

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moataz M Emara, MD, EDAIC

CONTACT

+201064048848; mm.emara@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blinded to the group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: March 4, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within one year after the completion of the study
• Access Criteria: Will be reported after completion of the study.

Locations

EG (1)