Ondansetron vs. Dexamethasone for Postoperative Nausea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2025-06-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexamethasone vs Ondansetron After Cesarean Delivery

NCT05692245

Nausea and Vomiting, Postoperative Cesarean Section Complications

COMPLETED PHASE4

Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department

NCT02985840

Nausea Abdominal Pain

TERMINATED PHASE4

Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting

NCT03297021

Post-operative Nausea and Vomiting

COMPLETED PHASE4

Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

NCT05265507

Postoperative Nausea and Vomiting

UNKNOWN PHASE4

Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy

NCT06729307

Esophagogastroduodensocopy (EGD) Procedure

NOT_YET_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Nausea and Vomiting (PONV)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study follows a randomized, parallel-group, single blinded placebo-controlled interventional design to assess the efficacy and safety of Ondansetron, Dexamethasone, and their combination in preventing postoperative nausea and vomiting (PONV).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This study will be single-blinded, meaning that the patients will not be aware of their assigned treatment group, but the healthcare provider administering the medication will know.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Placebo Group (Control)

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.

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type 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.

Arm 2: Ondansetron Group

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.

Group Type ACTIVE_COMPARATOR

Ondansetron (Zofran)

Intervention Type 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.

Arm 3: Dexamethasone Group

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type 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.

Arm: 4 Combination Therapy Group

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.

Group Type ACTIVE_COMPARATOR

Ondansetron (Zofran)

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo (Normal Saline)

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.

Intervention Type DRUG

Ondansetron (Zofran)

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.

Intervention Type DRUG

Dexamethasone

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Saline Injection Inert Solution Zofran Ondem Emeset Decadron Dexasone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No