Actively Recruiting
A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
Led by University of Malaya · Updated on 2025-04-25
74
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 years and above
- American Society of Anesthesiologists (ASA) class I-II
You will not qualify if you...
- Active smoker
- Obesity with body mass index (BMI) of 34 and above
- Body weight less than 30kg
- History of gastro-esophageal reflux disease (GERD) or other gastrointestinal diseases causing vomiting
- History of motion sickness
- Allergy to 5-HT3 (serotonin) receptor antagonists or dexamethasone
- Nausea or vomiting within 24 hours before surgery
- Use of antiemetics, steroids, or psychoactive medications within 24 hours before surgery
- History of cardiac arrhythmias
- Prolonged QT interval (QTc > 430ms in men or > 450ms in women)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Malaya
Pantai Valley, Kuala Lumpur, Malaysia, 59100
Actively Recruiting
2
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
Actively Recruiting
Research Team
K
Kenlee Liew, MBBS
CONTACT
S
Siti Nadzrah Yunus, MAnaes, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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