---
title: Ondansetron vs. Dexamethasone for Postoperative Nausea
nct_id: NCT06886230
overall_status: COMPLETED
phase: PHASE4
sponsor: Hafiz Muhammad Hamza
study_type: INTERVENTIONAL
primary_condition: Postoperative Nausea and Vomiting (PONV)
countries: Pakistan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06886230.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06886230"
ct_last_update_post_date: 2025-06-17
last_seen_at: "2026-05-12T06:31:21.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ondansetron vs. Dexamethasone for Postoperative Nausea

**Official Title:** Assessing The Safety and Efficacy of Ondansetron, Dexamethasone, and Their Combined Regimen in Managing Post Operative Nausea and Vomiting: A Randomized Controlled Trial

**NCT ID:** [NCT06886230](https://clinicaltrials.gov/study/NCT06886230)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 105
- **Lead Sponsor:** Hafiz Muhammad Hamza
- **Collaborators:** Federal Government Polyclinic (Postgraduate Medical Institute)
- **Conditions:** Postoperative Nausea and Vomiting (PONV)
- **Start Date:** 2025-03-20
- **Completion Date:** 2025-06-11
- **CT.gov Last Update:** 2025-06-17

## 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 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.

## 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 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Arm 1: Placebo Group (Control)** (PLACEBO_COMPARATOR) — Patients in this group will receive a placebo (normal saline) intravenously before surgery. This group serves as a control to compare the efficacy and safety of the active treatment regimens.
- **Arm 2: Ondansetron Group** (ACTIVE_COMPARATOR) — Patients in this group will receive a single dose of Ondansetron 4 mg IV before surgery. Ondansetron is a 5-hydroxytryptamine type 3 receptors antagonist commonly used for postoperative nausea and vomiting prevention.
- **Arm 3: Dexamethasone Group** (ACTIVE_COMPARATOR) — Patients in this group will receive a single dose of Dexamethasone 8 mg IV before surgery. Dexamethasone is a corticosteroid that has been shown to reduce postoperative nausea and vomiting.
- **Arm: 4 Combination Therapy Group** (ACTIVE_COMPARATOR) — Patients in this group will receive a combination of Ondansetron 4 mg IV and Dexamethasone 8 mg IV before surgery. The combination therapy is expected to have an additive effect in reducing PONV.

## Interventions

- **Placebo (Normal Saline)** (DRUG) — Patients in this group will receive an intravenous (IV) injection of normal saline before surgery. This serves as a control group to compare the efficacy of active treatment groups in preventing postoperative nausea and vomiting.
- **Ondansetron (Zofran)** (DRUG) — Patients in this group will receive a single intravenous (IV) dose of Ondansetron 4 mg before surgery. Ondansetron is a selective 5-HT3 receptor antagonist commonly used to prevent nausea and vomiting associated with anesthesia and surgery.
- **Dexamethasone** (DRUG) — Patients in this group will receive a single intravenous (IV) dose of Dexamethasone 8 mg before surgery. Dexamethasone is a corticosteroid with anti-inflammatory properties that has been shown to reduce the incidence of PONV by modulating inflammatory pathways and neuroreceptor activity.

## Primary Outcomes

- **Incidence of Postoperative Nausea and Vomiting (PONV)** _(time frame: 24 hours)_ — Defined as the presence of nausea and/or vomiting at any assessment time point (recovery, 2, 4, 6, 12, and 24 hours postoperatively).

Comparison of postoperative nausea and vomiting incidence between the Ondansetron-Dexamethasone and Ondansetron groups.

The need for rescue antiemetic administration as an indicator of postoperative nausea and vomiting severity.

## Secondary Outcomes

- **Severity of Postoperative Nausea and Vomiting (Postoperative Nausea and Vomiting Impact Scale Score)** _(time frame: 24 hours)_
- **Postoperative Pain Scores (Visual Analog Scale Score)** _(time frame: 24 hours)_
- **Need for Rescue Medication** _(time frame: 24 hours)_
- **Adverse Effects of Medications** _(time frame: 24 hours)_
- **Satisfaction with Postoperative Nausea and Vomiting Management** _(time frame: 24 hours)_
- **Apfel Score: Risk Assessment for Postoperative Nausea and Vomiting (PONV)** _(time frame: 24 hours)_
- **Heart Rate** _(time frame: 24 hours)_
- **Blood Pressure** _(time frame: 24 hours)_
- **Respiratory Rate** _(time frame: 24 hours)_
- **Oxygen Saturation** _(time frame: 24 hours)_

## Locations (1)

- Federal Government Polyclinic (Postgraduate Medical Institute), Islamabad, Capital, Pakistan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.federal government polyclinic (postgraduate medical institute)|islamabad|capital|pakistan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06886230.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06886230*  
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