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

Launched by UNIVERSITY OF MALAYA · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two medications, palonosetron and granisetron, to see which one works better to prevent nausea and vomiting after spine surgery in patients with scoliosis. Both medications are given along with another drug called dexamethasone to help keep patients comfortable after surgery. The study aims to find out if one medicine is more effective than the other, whether patients need extra medication for nausea, and how satisfied they are with their treatment.

To be eligible for this trial, participants need to be at least 10 years old and generally healthy, meaning they fall into certain categories defined by the American Society of Anesthesiologists. However, people who smoke, have certain health issues like obesity or heart problems, or have a history of severe nausea or vomiting before surgery won’t be able to participate. If someone joins the study, they will randomly receive either palonosetron or granisetron, and the researchers will monitor their nausea and vomiting at various times after surgery to see how well the medications work. This study is not yet recruiting participants, but it will provide valuable information to help improve care for patients undergoing scoliosis surgery.

Gender

ALL

Eligibility criteria

• 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)