CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
Palonosetron +1 moredrug
Likely dose
Palonosetron 1.5mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05956899
NCT05956899Phase 4Completed

A Comparison Between Palonosetron And Ondansetron As Prophylaxis Against Postoperative Nausea and Vomiting In Idiopathic Scoliosis Surgery: A Randomised Trial

University of Malaya·interventional·Posted Jul 24, 2023·Updated Dec 10, 2024

In Brief

A Phase 4 clinical trial evaluating Palonosetron and Ondansetron for Idiopathic Scoliosis and Postoperative Nausea and Vomiting. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedJul 24, 2023
Enrollment StartJun 1, 2023
Primary CompletionMar 20, 2024
Study CompletionMay 2, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.9 years ago

Interventions

Palonosetrondrug

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

Ondansetrondrug

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