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

April 22, 2025 updated by: Dr. Siti Nadzrah Yunus, University of Malaya

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 patients and up to 80% in high-risk patients. Idiopathic scoliosis is a common form of structural spinal deformities with a Cobb angle of >/ 10 degrees. It affects young females in the early pubertal stage more than young men by 1% and 4%.

Posterior spinal fusion (PSF) surgery is commonly performed in patients with severe scoliosis. It is a long complex surgery inflicting extensive surgical field requiring opioids as the mainstay of analgesia during the perioperative period. These targeted population are particularly adolescent female requiring intraoperative and postoperative opioids who are at high risk of developing PONV.

Dexamethasone and anti-serotonergic drugs like granisetron are commonly used antiemetics due to their efficacy and safety profiles. Dexamethasone is particularly favoured for its long duration of action and pain-reducing effects.

Palonosetron, a second-generation anti-serotonergic drug, has a unique pharmacokinetic profile with a prolonged duration of action. It may be more beneficial for patients on prolonged opioid-based analgesic regimens. However, its higher cost and inconsistent study findings limit its widespread use, especially in scoliosis patients undergoing spinal fusion surgery.

Total intravenous anaesthesia (TIVA) is recommended for high-risk PONV patients, as it reduces the emetogenic effect of volatile anaesthetics. Propofol, used in TIVA, is itself an effective antiemetic. TIVA with propofol has been shown to be as effective as giving a single antiemetic and can further reduce the risk of PONV when combined with other prophylactic antiemetics.

The standard practice for managing PONV involves the administration of two antiemetics and considering TIVA for high-risk patients. This study aims to compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone in scoliosis patients undergoing spinal fusion under TIVA. The study will also evaluate the number of rescue antiemetics needed, assess adverse effects, and measure patient satisfaction.

The study will be randomized and double-blinded, to be conducted in University Malaya Medical Centre (UMMC). The sample size is calculated to be 92 participants, after taking into account a 20% dropout rate. Adult and adolescent idiopathic scoliosis patients undergoing PSF surgery will be eligible for the study. Written informed consent will be obtained from participants or their guardians, and assent will be obtained from adolescent participants. Patients will be randomized to receive either palonosetron or ondansetron along with dexamethasone.

The study will follow standard anaesthetic techniques, including TIVA with remifentanil and propofol. Intravenous injections of the study drugs or placebo will be given during surgery, and dexamethasone will be administered as a baseline antiemetic. Morphine will be administered before the end of surgery for pain management.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • University Malaya Medical Centre
        • Contact:
          • Nantni Kumaran, MD
    • Kuala Lumpur
      • Pantai Valley, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya
        • Contact:
        • Sub-Investigator:
          • Siti Nadzrah Yunus, Postgraduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Palonosetron Group (Group P)
Group P will receive a stat dose of IV palonosetron 1.5mcg/kg diluted in a 5ml preparation of normal saline 0.9% prior to the commencement of general anaesthesia. At the start of wound closure, Group P will receive a 5ml preparation of normal saline 0.9% as a placebo.
Drug: Palonosetron (Group P)
Group P will be receiving palonosetron 1.5mcg/kg before the commencement of general anaesthesia
Other Names:
  • antiemetic
Active Comparator: Granisetron Group (Group G)
Group G will receive a 5ml preparation of normal saline 0.9% as placebo prior to commencement of general anaesthesia. At the start of wound closure, a stat dose of IV granisetron 1mg in 5ml preparation will be administered.
Drug: Granisetron (Group G)
Group G participants will receive IV Granisetron 1mg at the start of wound closure
Other Names:
  • antiemetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative nausea and vomiting (PONV) delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients
Time Frame: At 1 hour after surgery
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)
Time Frame: At 4 hours after surgery
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)
Time Frame: At 12 hours after surgery
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)
Time Frame: At 24 hours after surgery
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)
Time Frame: At 48 hours after surgery
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

Outcome Measure
Measure Description
Time Frame
To evaluate the need for rescue antiemetics among participants
Time Frame: At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery
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.
Time Frame: 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.
At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery
To assess the degree of participant's satisfaction.
Time Frame: At 48 hours after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Nantni Kumaran, MBBS, University of Malaya
  • Principal Investigator: Mohd Shahnaz Hasan, MAnaes, MBBS, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202464-13794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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