Comparing two medications for preventing nausea after scoliosis surgery
A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial
PHASE4 · University of Malaya · NCT06540885
This study is testing which of two nausea medications works better for teenage girls having surgery for scoliosis to help prevent them from feeling sick afterward.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | University of Malaya (other) |
| Locations | 2 sites (Pantai Valley, Kuala Lumpur and 1 other locations) |
| Trial ID | NCT06540885 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two antiemetic medications, palonosetron and granisetron, in preventing postoperative nausea and vomiting (PONV) in patients with idiopathic scoliosis undergoing posterior spinal fusion surgery. Both medications will be administered alongside dexamethasone as part of the anesthesia regimen. Participants will be randomly assigned to receive either palonosetron or granisetron, and the study will evaluate their effectiveness in reducing PONV, the need for rescue antiemetics, and any adverse effects. The trial focuses on a high-risk population, particularly adolescent females, who are more susceptible to PONV due to opioid use during surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and adults aged 10 years and older with idiopathic scoliosis scheduled for spinal fusion surgery.
Not a fit: Patients with a history of gastrointestinal diseases, allergies to study medications, or those who are active smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of postoperative nausea and vomiting in scoliosis patients, enhancing their recovery experience.
How similar studies have performed: Previous studies have shown varying success with similar antiemetic approaches, but this specific comparison in scoliosis patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 10 years and above * American Society of Anesthesiologists (ASA) class I-II Exclusion Criteria: * Active smoker * Obesity with body mass index (BMI) of 34 and above * Body weight of less than 30kg * History of gastro-esophageal reflux disease (GERD)/ other gastrointestinal diseases associated with vomiting * History of motion sickness * History of allergy to 5-HT3 (serotonin) receptor antagonists or dexamethasone * History of nausea or vomiting withing 24 hours before surgery * History of administration of antiemetics/ steroids/ psychoactive medications within 24 hours before the surgery * History of cardiac arrhythmias * Prolonged QT (QTc is prolonged if \> 430ms in men or \>450ms in women)
Where this trial is running
Pantai Valley, Kuala Lumpur and 1 other locations
- University Malaya — Pantai Valley, Kuala Lumpur, Malaysia (RECRUITING)
- University Malaya Medical Centre — Kuala Lumpur, Malaysia (RECRUITING)
Study contacts
- Principal investigator: Nantni Kumaran, MBBS — University of Malaya
- Study coordinator: Kenlee Liew, MBBS
- Email: drkenliew@gmail.com
- Phone: +60195753579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Nausea and Vomiting, Scoliosis, Antiemetics, Granisetron, Palonosetron