Ondansetron vs. Dexamethasone for Postoperative Nausea

Hafiz Muhammad Hamza

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting (PONV)

Treatments: Drug: Placebo (Normal Saline); Drug: Dexamethasone; Drug: Ondansetron (Zofran)

Study type: Interventional

Funder types: Other

Identifiers

NCT06886230

FGPC.1/12/2024 E-Committee

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 4 patient groups, including a placebo group

Arm 1: Placebo Group (Control)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (Normal Saline)

Arm 2: Ondansetron Group

Active Comparator group

Description:

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.

Treatment:

Drug: Ondansetron (Zofran)

Arm 3: Dexamethasone Group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone

Arm: 4 Combination Therapy Group

Active Comparator group

Description:

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.

Treatment:

Drug: Ondansetron (Zofran)

Drug: Dexamethasone