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Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

NCT05998317 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-25

No results posted yet for this study

Summary

Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.

A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.

Conditions

  • Postoperative Nausea and Vomiting
  • Postoperative Pain
  • Laparoscopic Cholecystectomy

Interventions

DRUG

At-night Dexamethasone

Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.

DRUG

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 sensation in injection.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Moataz M Emara, MD, EDAIC · Mansoura University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-08
Primary Completion
2023-11-15
Completion
2023-11-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998317 on ClinicalTrials.gov