Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

• Status: Completed
• Trial end date: 2023-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• patient refusal

• use of steroids or antiemetic agents within 1 week of surgery

• chronic opioid therapy

• history of allergy to any study medications

• serum creatinine > 1.4 mg/dl

• liver enzymes more than triple normal limits

• pregnancy

• psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire

• Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.