Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

NCT05956899 | Completed Phase 4

• 1 other identifier: 20221016-11624
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of two antiemetic drugs, palonosetron and ondansetron, when given alongside dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis undergoing posterior spinal fusion surgery under total intravenous anesthesia (TIVA). The main questions the study aims to answer are:

• How effective is palonosetron compared to ondansetron, 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 ondansetron 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.

Conditions

Idiopathic Scoliosis; Postoperative Nausea and Vomiting

Keywords

Antiemetics; Dexamethasone; Ondansetron; Palonosetron; Scoliosis; PONV

Outcome Measures

Primary Outcomes (5)

• Incidence of PONV

  To compare the effectiveness of palonosetron and ondansetron 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 PONV

  To compare the effectiveness of palonosetron and ondansetron 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 PONV

  To compare the effectiveness of palonosetron and ondansetron 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 PONV

  To compare the effectiveness of palonosetron and ondansetron 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 PONV

  To compare the effectiveness of palonosetron and ondansetron 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 Outcomes (3)

• Number of Participants Developing Postoperative Nausea Vomiting Requiring Rescue Antiemetic Within 48 hours After Surgery

  At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery

• Number of Participants Developing Adverse Effects Related to the Study Drugs.

  Overall, assessed at 48 hours after surgery

• Degree of patient satisfaction as represented on the Visual Analogue Scale

  Overall, assessed at 48 hours after surgery

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive a stat dose of IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia.

Drug: Palonosetron

Group B

ACTIVE COMPARATOR

Group B will receive a stat dose of IV ondansetron 0.15mg/kg at the start of wound closure.

Drug: Ondansetron

Interventions

Palonosetron DRUG

IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia

Group A

Ondansetron DRUG

IV ondansetron 0.15mg/kg at the start of wound closure

Group B

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 10 years and above
• American Society of Anaesthesiologists (ASA) I-II Physical Status

You may not qualify if:

• History of allergy to serotonin receptor antagonists or dexamethasone
• Obesity with a body mass index (BMI) of 34 and above
• Body weight of less than 30kg
• Active smoker
• History of gastroesophageal reflux disease/ other gastrointestinal diseases associated with vomiting
• History of motion sickness
• History of nausea or vomiting within 24 hours before the surgery
• Administration of antiemetics/ steroids/ psychoactive medications within 24 hours before the surgery
• Require mechanical ventilation postoperatively
• History of cardiac arrhythmias
• Prolonged QT (QTc is prolonged if \> 440ms in men or \> 460ms in women

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya

Pantai Valley, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (18)

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MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Scoliosis

Interventions

Palonosetron; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Siti Nadzrah Binti Yunus, MAnaes, MBBS

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: After taking informed consent and recruitment of eligible participants, they will be randomized using a sequentially numbered, opaque sealed envelope (SNOSE) method. 74 radio-opaque envelopes will be prepared according to two groups: 37 participants for each Group A, Palonosetron and Group B, Ondansetron. Group A will receive IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia; while Group B will receive IV ondansetron 0.15mg/kg at the start of wound closure.

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: July 24, 2023
• Study Start: June 1, 2023
• Primary Completion: March 20, 2024
• Study Completion: May 2, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)