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Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

NCT05956899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-12-10

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effectiveness of two antiemetic drugs, palonosetron and ondansetron, when given alongside dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis undergoing posterior spinal fusion surgery under total intravenous anesthesia (TIVA).

The main questions the study aims to answer are:

* How effective is palonosetron compared to ondansetron, both combined with dexamethasone, in preventing PONV after scoliosis surgery?
* Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups?

Participants in the study will be randomly assigned to receive either palonosetron or ondansetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.

Conditions

  • Idiopathic Scoliosis
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Palonosetron

IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia

DRUG

Ondansetron

IV ondansetron 0.15mg/kg at the start of wound closure

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Siti Nadzrah Binti Yunus, MAnaes, MBBS · Universiti Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-03-20
Completion
2024-05-02

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956899 on ClinicalTrials.gov