Phase
Condition
Lactose Intolerance
Colic
Vomiting
Treatment
Dexamethasone
Placebo (Normal Saline)
Ondansetron (Zofran)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients (≥18 years) scheduled for elective surgery under anesthesia.
Patients at moderate to high risk for postoperative nausea and vomiting (PONV), asdetermined by an Apfel risk score ≥2.
Patients able to provide informed consent or have a legally authorizedrepresentative provide consent.
Exclusion
Exclusion Criteria:
Known allergy or hypersensitivity to Ondansetron, Dexamethasone, or any of theircomponents.
History of significant adverse reactions to previous PONV prophylaxis withOndansetron or Dexamethasone.
Pre-existing conditions or medications contraindicating the use of Ondansetron orDexamethasone, e.g. QT prolongation or severe cardiac arrhythmias (e.g., torsades depointes, congenital long QT syndrome), Uncontrolled hypertension (for Dexamethasoneuse), 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 beingstudied).
Chronic opioid users (≥3 months of continuous opioid use), as this may alter PONVrisk and response to prophylaxis.
Study Design
Study Description
Connect with a study center
Federal Government Polyclinic (Postgraduate Medical Institute)
Islamabad, Capital 051
PakistanActive - Recruiting
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