Status:

RECRUITING

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

Lead Sponsor:

University of Malaya

Conditions:

Postoperative Nausea and Vomiting

Scoliosis

Eligibility:

All Genders

10+ years

Phase:

PHASE4

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 measur...

Detailed Description

Postoperative nausea and vomiting (PONV) remains a common adverse event after surgery and anaesthesia causing much dissatisfaction among patients. PONV incidence is reported at 30% in all surgical pat...

Eligibility Criteria

Inclusion

  • Age: 10 years and above
  • American Society of Anesthesiologists (ASA) class I-II

Exclusion

  • 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)

Key Trial Info

Start Date :

January 6 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

74 Patients enrolled

Trial Details

Trial ID

NCT06540885

Start Date

January 6 2025

End Date

September 30 2026

Last Update

April 25 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University Malaya

Pantai Valley, Kuala Lumpur, Malaysia, 59100

2

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 50603