Ondansetron vs. Dexamethasone for Postoperative Nausea

Phase

Condition

Lactose Intolerance

Vomiting

Colic

Treatment

Ondansetron (Zofran)

Dexamethasone

Placebo (Normal Saline)

Clinical Study ID

NCT06886230

FGPC.1/12/2024 E-Committee

Ages 18-65
All Genders

Study 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 undergoing surgery under anesthesia. A total of 100 patients will be randomized into four groups: Placebo, Ondansetron, Dexamethasone, and Ondansetron-Dexamethasone combination. The primary outcome will be the incidence of PONV within 24 hours post-surgery, while secondary outcomes include severity of symptoms, need for rescue medication, adverse effects, and patient satisfaction.

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

Ondansetron (Zofran)

March 20, 2025

June 11, 2025

Study 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 effectiveness of Ondansetron, Dexamethasone, and their combination for PONV prevention.

The study will be conducted as a randomized, controlled trial at Federal Polyclinic Hospital Islamabad over four months. A total of 100 adult patients undergoing elective surgery under anesthesia will be enrolled and randomly allocated into one of four groups (n=25 each):

Placebo group - Receives no prophylactic antiemetic treatment. Ondansetron group - Receives 4 mg IV Ondansetron before surgery. Dexamethasone group - Receives 8 mg IV Dexamethasone before surgery. Ondansetron-Dexamethasone group - Receives 4 mg IV Ondansetron + 8 mg IV Dexamethasone before surgery.

Methodology:

Patients will be assessed at multiple time points (2, 4, 6, 12, and 24 hours postoperatively) for PONV incidence and severity, along with the need for rescue medication. Side effects such as headache, dizziness, hypertension, and hyperglycemia will also be monitored.

Statistical Analysis:

Data will be analyzed using chi-square tests and ANOVA to compare outcomes across treatment groups. A p-value < 0.05 will be considered statistically significant.

This study will help determine the most effective and safest antiemetic regimen, guiding clinical decision-making for better PONV management.

Connect with a study center

Federal Government Polyclinic (Postgraduate Medical Institute)
Islamabad, Capital 051
Pakistan
Site Not Available

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