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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: t
View:

• Age: 10 years and above

• American Society of Anesthesiologists (ASA) class I-II

Locations
Other Locations
Malaysia
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
University Malaya
RECRUITING
Pantai Valley
Contact Information
Primary
Kenlee Liew, MBBS
drkenliew@gmail.com
+60195753579
Backup
Siti Nadzrah Yunus, MAnaes, MBBS
siti.nadzrah@ummc.edu.my
+60176975009
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 74
Treatments
Experimental: Palonosetron Group (Group P)
Group P will receive a stat dose of IV palonosetron 1.5mcg/kg diluted in a 5ml preparation of normal saline 0.9% prior to the commencement of general anaesthesia. At the start of wound closure, Group P will receive a 5ml preparation of normal saline 0.9% as a placebo.
Active_comparator: Granisetron Group (Group G)
Group G will receive a 5ml preparation of normal saline 0.9% as placebo prior to commencement of general anaesthesia. At the start of wound closure, a stat dose of IV granisetron 1mg in 5ml preparation will be administered.
Related Therapeutic Areas
Sponsors
Leads: University of Malaya

This content was sourced from clinicaltrials.gov