Using oral dexamethasone to prevent nausea after gallbladder surgery
Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
PHASE3 · Mansoura University · NCT06288035
This study is testing if taking oral dexamethasone before gallbladder surgery can help prevent nausea and vomiting just as well as getting it through an IV.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 814 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University (other) |
| Locations | 1 site (Mansoura, Aldakahlia) |
| Trial ID | NCT06288035 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of administering oral dexamethasone 12 hours before elective laparoscopic cholecystectomy to prevent postoperative nausea and vomiting (PONV). It is a parallel, two-arm, randomized controlled trial comparing oral dexamethasone to intravenous dexamethasone given at the time of anesthesia induction. The primary outcome measured will be the incidence of PONV in a total of 814 adult participants with ASA physical status I-III. The goal is to determine if oral dexamethasone is non-inferior to the standard intravenous method while being easier to administer.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy.
Not a fit: Patients who have received steroids or antiemetics within a week of surgery, or those with certain medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more convenient and effective method to prevent nausea and vomiting after gallbladder surgery.
How similar studies have performed: Previous studies have shown that dexamethasone is effective in preventing PONV, making this approach a promising adaptation of established methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mansoura, Aldakahlia
- Mansoura University Faculty of Medicine — Mansoura, Aldakahlia, Egypt (RECRUITING)
Study contacts
- Principal investigator: Moataz M Emara, MD, EDAIC — Mansoura University Hospital
- Study coordinator: Moataz M Emara, MD, EDAIC
- Email: mm.emara@mans.edu.eg
- Phone: +201064048848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Nausea and Vomiting