Comparing Ondansetron and Dexamethasone for preventing nausea after surgery
Assessing The Safety and Efficacy of Ondansetron, Dexamethasone, and Their Combined Regimen in Managing Post Operative Nausea and Vomiting: A Randomized Controlled Trial
This study is testing whether Ondansetron, Dexamethasone, or a mix of both can help prevent nausea and vomiting in adults after they have surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Federal Government Polyclinic (Postgraduate Medical Institute) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Islamabad, Capital and 1 other locations) |
| Trial ID | NCT06886230 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the safety and efficacy of Ondansetron, Dexamethasone, and their combination in preventing postoperative nausea and vomiting (PONV) in adult patients undergoing elective surgery. A total of 100 patients will be randomly assigned to one of four groups: placebo, Ondansetron, Dexamethasone, or a combination of both. The primary outcome is the incidence of PONV within 24 hours post-surgery, while secondary outcomes include symptom severity, need for rescue medication, adverse effects, and patient satisfaction. The study will be conducted at the Federal Polyclinic Hospital Islamabad over four months.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older scheduled for elective surgery under anesthesia with a moderate to high risk for PONV.
Not a fit: Patients with known allergies to Ondansetron or Dexamethasone, or those with contraindications to these medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer regimen for preventing postoperative nausea and vomiting, improving patient recovery and satisfaction.
How similar studies have performed: Previous studies have shown varying success in using Ondansetron and Dexamethasone for PONV management, making this approach both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) scheduled for elective surgery under anesthesia. * Patients at moderate to high risk for postoperative nausea and vomiting (PONV), as determined by an Apfel risk score ≥2. * Patients able to provide informed consent or have a legally authorized representative provide consent. Exclusion Criteria: * Known allergy or hypersensitivity to Ondansetron, Dexamethasone, or any of their components. * History of significant adverse reactions to previous PONV prophylaxis with Ondansetron or Dexamethasone. * Pre-existing conditions or medications contraindicating the use of Ondansetron or Dexamethasone, e.g. QT prolongation or severe cardiac arrhythmias (e.g., torsades de pointes, congenital long QT syndrome), Uncontrolled hypertension (for Dexamethasone use), Severe hepatic impairment (Child-Pugh C) or end-stage renal disease, Uncontrolled diabetes mellitus (due to Dexamethasone-induced hyperglycemia). * Patients with active malignancy undergoing chemotherapy or radiotherapy. * Pregnant or lactating women (unless safety in this population is specifically being studied). * Chronic opioid users (≥3 months of continuous opioid use), as this may alter PONV risk and response to prophylaxis.
Where this trial is running
Islamabad, Capital and 1 other locations
- Federal Government Polyclinic (Postgraduate Medical Institute) — Islamabad, Capital, Pakistan (Not_yet_recruiting)
- Federal Government Polyclinic (Postgraduate Medical Institute) — Islamabad, Capital, Pakistan (Recruiting)
Study contacts
- Principal investigator: Naveed Ullah Khan, Consultant surgery, HOD — Federal Government Polyclinic (Postgraduate Medical Institute)
- Study coordinator: Hafiz Muhammad Hamza, MBBS
- Email: 2015n1488@gmail.com
- Phone: +923365329544
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.