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RECRUITING
NCT06540885
PHASE4

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

Sponsor: University of Malaya

View on ClinicalTrials.gov

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.

Official title: A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2025-01-06

Completion Date

2026-09-30

Last Updated

2025-04-25

Healthy Volunteers

Yes

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

Locations (2)

University Malaya

Pantai Valley, Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia