Clinical trial NCT06886230: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting (PONV)
Keywords: nausea
vomiting
PONV
randomized controlled trial
ondansetron
dexamethasone
Lead sponsor: Federal Government Polyclinic (Postgraduate Medical Institute)
Sponsor class: OTHER
Collaborators: name: Federal Government Polyclinic (Postgraduate Medical Institute)
First posted: 2025-03-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of Postoperative Nausea and Vomiting (Postoperative Nausea and Vomiting Impact Scale Score)
timeFrame: 24 hours
measure: Postoperative Pain Scores (Visual Analog Scale Score)
timeFrame: 24 hours
measure: Need for Rescue Medication
timeFrame: 24 hours
measure: Adverse Effects of Medications
timeFrame: 24 hours
measure: Satisfaction with Postoperative Nausea and Vomiting Management
timeFrame: 24 hours
measure: Apfel Score: Risk Assessment for Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hours
measure: Heart Rate
timeFrame: 24 hours
measure: Blood Pressure
timeFrame: 24 hours
measure: Respiratory Rate
timeFrame: 24 hours
measure: Oxygen Saturation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Federal Government Polyclinic (Postgraduate Medical Institute)
state: Capital
Study officials:
affiliation: Federal Government Polyclinic (Postgraduate Medical Institute)
name: Naveed Ullah Khan, Consultant surgery, HOD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.