RecruitingPhase 4NCT06540885

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

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


Sponsor

University of Malaya

Enrollment

74 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 Years

Inclusion Criteria2

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

Exclusion Criteria10

  • 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)

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Interventions

DRUGPalonosetron (Group P)

Group P will be receiving palonosetron 1.5mcg/kg before the commencement of general anaesthesia

DRUGGranisetron (Group G)

Group G participants will receive IV Granisetron 1mg at the start of wound closure


Locations(2)

University Malaya

Pantai Valley, Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

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NCT06540885


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