Actively Recruiting

Phase 4
Age: 10Years +
All Genders
Healthy Volunteers
ID06540885

Comparison of Palonosetron Versus Granisetron to Prevent Postoperative Nausea and Vomiting in Idiopathic Scoliosis Spine Surgery Patients

Led by University of Malaya · Updated on 2025-04-25

74

Participants Needed

2

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two antiemetic drugs, palonosetron and granisetron, to prevent early and delayed postoperative nausea and vomiting (PONV) in adolescents and adults with idiopathic scoliosis undergoing posterior spinal fusion surgery. The study focuses on patients receiving total intravenous anesthesia (TIVA) and evaluates the effectiveness of these drugs when combined with dexamethasone, a commonly used medication to reduce nausea and pain. The trial also aims to assess rescue antiemetic use, drug-related side effects, and patient satisfaction. Participants will be randomly assigned to receive either palonosetron at 1.5 mcg/kg before anesthesia or granisetron 1 mg intravenously at the start of wound closure. Both groups will receive dexamethasone as a baseline antiemetic. The surgery involves TIVA with remifentanil and propofol, and morphine will be administered before the end of surgery for pain management. The study is double-blinded and conducted at University Malaya Medical Centre with an estimated sample size of 92 patients. Participants will be monitored closely for nausea and vomiting at 1, 4, 12, 24, and 48 hours after surgery. Researchers will evaluate the incidence and severity of PONV, the need for additional antiemetics, adverse effects, and patient satisfaction. Standard anesthetic techniques and pain assessments will be followed throughout. The total participation period includes surgery and postoperative monitoring up to 48 hours.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 10 years and above
  • American Society of Anesthesiologists (ASA) class I-II
Not Eligible

You will not qualify if you...

  • Active smoker
  • Obesity with body mass index (BMI) of 34 and above
  • Body weight less than 30kg
  • History of gastro-esophageal reflux disease (GERD) or other gastrointestinal diseases causing vomiting
  • History of motion sickness
  • Allergy to 5-HT3 (serotonin) receptor antagonists or dexamethasone
  • Nausea or vomiting within 24 hours before surgery
  • Use of antiemetics, steroids, or psychoactive medications within 24 hours before surgery
  • History of cardiac arrhythmias
  • Prolonged QT interval (QTc > 430ms in men or > 450ms in women)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Malaya

Pantai Valley, Kuala Lumpur, Malaysia, 59100

Actively Recruiting

2

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 50603

Actively Recruiting

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Research Team

K

Kenlee Liew, MBBS

S

Siti Nadzrah Yunus, MAnaes, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Propofol vs. inhalational agents to maintain general anaesthesia in ambulatory and in-patient surgery: a systematic review and meta-analysis.

Stefan Schraag, Lorenzo Pradelli, Abdul Jabbar Omar Alsaleh...

https://pubmed.ncbi.nlm.nih.gov/30409186

Total intravenous anaesthesia versus single-drug pharmacological antiemetic prophylaxis in adults: A systematic review and meta-analysis.

Maximilian S Schaefer, Peter Kranke, Stephanie Weibel...

https://pubmed.ncbi.nlm.nih.gov/27454663

Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials.

Emmanuel Marret, Okba Kurdi, Paul Zufferey...

https://pubmed.ncbi.nlm.nih.gov/15915040

Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials.

Nadia Elia, Christopher Lysakowski, Martin R Tramèr

https://pubmed.ncbi.nlm.nih.gov/16306743