NCT06540885 A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
| NCT ID | NCT06540885 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Malaya |
| Condition | Postoperative Nausea and Vomiting |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 74 participants in total. It began in 2025-01-06 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Nantni Kumaran, MBBS
PRINCIPAL INVESTIGATOR
University of Malaya
Frequently Asked Questions
Who can join the NCT06540885 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Postoperative Nausea and Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06540885 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06540885 currently recruiting?
Yes, NCT06540885 is actively recruiting participants. Contact the research team at drkenliew@gmail.com for enrollment information.
Where is the NCT06540885 trial being conducted?
This trial is being conducted at Pantai Valley, Malaysia, Kuala Lumpur, Malaysia.
Who is sponsoring the NCT06540885 clinical trial?
NCT06540885 is sponsored by University of Malaya. The principal investigator is Nantni Kumaran, MBBS at University of Malaya. The trial plans to enroll 74 participants.