Status:
COMPLETED
Ondansetron vs. Dexamethasone for Postoperative Nausea
Lead Sponsor:
Hafiz Muhammad Hamza
Collaborating Sponsors:
Federal Government Polyclinic (Postgraduate Medical Institute)
Conditions:
Postoperative Nausea and Vomiting (PONV)
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This randomized controlled trial aims to evaluate the safety and efficacy of Ondansetron, Dexamethasone, and their combination in managing postoperative nausea and vomiting (PONV) in patients undergoi...
Detailed Description
Postoperative nausea and vomiting (PONV) is a common and distressing complication following surgery, affecting patient recovery and satisfaction. This study aims to compare the safety and effectivenes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06886230
Start Date
March 20 2025
End Date
June 11 2025
Last Update
June 17 2025
Active Locations (1)
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1
Federal Government Polyclinic (Postgraduate Medical Institute)
Islamabad, Capital, Pakistan, 051