Ondansetron vs. Dexamethasone for Postoperative Nausea

NCT06886230 | Completed Phase 4

• 1 other identifier: FGPC.1/12/2024 E-Committee
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting (PONV)

Keywords

nausea; vomiting; PONV; randomized controlled trial; ondansetron; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Nausea and Vomiting (PONV)

  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.

  24 hours

Secondary Outcomes (10)

• Severity of Postoperative Nausea and Vomiting (Postoperative Nausea and Vomiting Impact Scale Score)

  24 hours

• Postoperative Pain Scores (Visual Analog Scale Score)

  24 hours

• Need for Rescue Medication

  24 hours

• Adverse Effects of Medications

  24 hours

• Satisfaction with Postoperative Nausea and Vomiting Management

  24 hours

Study Arms (4)

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.

Drug: Placebo (Normal Saline)

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.

Drug: Ondansetron (Zofran)

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.

Drug: Dexamethasone

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.

Drug: Ondansetron (Zofran); Drug: Dexamethasone

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.

Also known as: Saline Injection, Inert Solution

Arm 1: Placebo Group (Control)

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.

Also known as: Zofran, Ondem, Emeset

Arm 2: Ondansetron Group; Arm: 4 Combination Therapy Group

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.

Also known as: Decadron, Dexasone

Arm 3: Dexamethasone Group; Arm: 4 Combination Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hafiz Muhammad Hamza: lead
• Federal Government Polyclinic (Postgraduate Medical Institute): collaborator

Study Sites (1)

Federal Government Polyclinic (Postgraduate Medical Institute)

Islamabad, Capital, 051, Pakistan

Location

Related Publications (3)

• Bhattarai B, Shrestha S, Singh J. Comparison of ondansetron and combination of ondansetron and dexamethasone as a prophylaxis for postoperative nausea and vomiting in adults undergoing elective laparoscopic surgery. J Emerg Trauma Shock. 2011 Apr;4(2):168-72. doi: 10.4103/0974-2700.82200.

  PMID: 21769200 BACKGROUND

• Thanuja IL, Parida S, Mishra SK, Badhe AS. Effect of combinations of dexamethasone-ondansetron and dexamethasone-ondansetron-aprepitant versus aprepitant alone for early postoperative nausea and vomiting after day care gynaecological laparoscopy: A randomised clinical trial. Indian J Anaesth. 2021 Jun;65(6):465-470. doi: 10.4103/ija.IJA_119_21. Epub 2021 Jun 22.

  PMID: 34248190 BACKGROUND

• Bilgen S, Kizilcik N, Haliloglu M, Yildirim G, Kaspar EC, Koner O. Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):373-380. doi: 10.10.5152/TJAR.2018.53179. Epub 2018 Sep 4.

  PMID: 30263861 BACKGROUND

Related Links

• Dexamethasone, ondansetron, and their combination and postoperative nausea and vomiting in children undergoing strabismus surgery: a meta-analysis of randomized controlled trials

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Saline Solution; Sodium Chloride; Ondansetron; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Naveed Ullah Khan, Consultant surgery, HOD

  Federal Government Polyclinic (Postgraduate Medical Institute)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: House Officer, Foundation University School of Health Sciences

Model Details: 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).

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 20, 2025
• Study Start: March 20, 2025
• Primary Completion: June 10, 2025
• Study Completion: June 11, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-03

Locations

PA (1)