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A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery

NCT06540885 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-08-20

No results posted yet for this study

Summary

The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA).

The main questions the study aims to answer are:

How effective is palonosetron compared to granisetron, when 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 granisetron 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

  • Postoperative Nausea and Vomiting
  • Scoliosis

Interventions

DRUG

Palonosetron (Group P)

Group P will be receiving palonosetron 1.5mcg/kg before the commencement of general anaesthesia

DRUG

Granisetron (Group G)

Group G participants will receive IV Granisetron 1mg at the start of wound closure

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Nantni Kumaran, MBBS · University of Malaya

  • Mohd Shahnaz Hasan, MAnaes, MBBS · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2025-11-30
Completion
2026-07-31

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 NCT06540885 on ClinicalTrials.gov