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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Malaya

About this trial

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

Qualifiers

Age: 10 years and above

American Society of Anesthesiologists (ASA) class I-II

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Palonosetron (Group P)
  • Granisetron (Group G)

Treatment groups

74 Participants
are divided into 2 treatment groups

Sponsors and collaborators