A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
NCT Number: NCT06540885
Acronym: PONV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Postoperative Nausea and Vomiting|Scoliosis
Interventions: DRUG: Palonosetron (Group P)|DRUG: Granisetron (Group G)
Sponsor: University of Malaya
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-09-30
Locations: University Malaya, Pantai Valley, Kuala Lumpur, 59100, Malaysia

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.

Primary Outcome Measures: Incidence of postoperative nausea and vomiting (PONV) delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients, To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia., At 1 hour after surgery|Incidence of postoperative nausea and vomiting (PONV), To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia., At 4 hours after surgery|Incidence of postoperative nausea and vomiting (PONV), To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia., At 12 hours after surgery|Incidence of postoperative nausea and vomiting (PONV), To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia., At 24 hours after surgery|Incidence of postoperative nausea and vomiting (PONV), To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia., At 48 hours after surgery
Secondary Outcome Measures: To evaluate the need for rescue antiemetics among participants, Number of Participants Developing Postoperative Nausea Vomiting Requiring Rescue Antiemetic Within 48 hours After Surgery Any occurrence of severe nausea and retching with visual analogue scale score ≥4; and vomiting of 1 or more episodes will be treated with the rescue drug IV metoclopramide. For adolescent subjects (aged less than 18 years old), IV metoclopramide will be given at 0.2mg/kg, with a maximum dose of 10 mg intravenously up to 3 times per day. For adult patients (18 years old and above), IV metoclopramide 10mg will be given, up to 3 times per day. If there is any further occurrence of PONV within 8 hours of administration of IV metoclopramide, a second line of rescue antiemetic, IV Granisetron 1mg, will be administered to participants in both arms of the study. The administration of any rescue medications will be recorded and taken into account during data processing., At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery|To evaluate the adverse effects related to the study drugs., Number of Participants Developing Adverse Effects Related to the Study Drugs., At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery|To assess the degree of participant's satisfaction., Degree of patient satisfaction as represented on the Likert scale Selection of a number from a scale of 1 (least satisfied) to 5 (most satisfied), At 48 hours after surgery