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Compares treatment options for Postoperative Nausea and Vomiting
Official title A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
ClinicalTrials.gov ID: NCT06540885
What this study is testing
What is Palonosetron (Group P)?
Palonosetron (Group P) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postoperative nausea and vomiting.
Also referred to as antiemetic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age: 10 years and above
- American Society of Anesthesiologists (ASA) class I-II
You likely can't join if
- 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
See the full eligibility criteria
- Age: 10 years and above
- American Society of Anesthesiologists (ASA) class I-II
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Pantai Valley, Kuala Lumpur, Malaysia
- Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pantai Valley, Kuala Lumpur, Malaysia; Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.