An update on the management of postoperative nausea and vomiting.
Xuezhao Cao, Paul F White, Hong Ma
https://pubmed.ncbi.nlm.nih.gov/28455599Actively Recruiting
Phase 4
Age: 10Years +
All Genders
Healthy Volunteers
ID06540885
A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial
Led by University of Malaya · Updated on 2025-04-25
74
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness of two serotonin receptor blockers, palonosetron and granisetron, given with dexamethasone to prevent early and delayed postoperative nausea and vomiting (PONV) in adolescents and adults with idiopathic scoliosis undergoing posterior spinal fusion surgery using total intravenous anesthesia (TIVA). The study aims to find out which drug better prevents nausea and vomiting, the need for rescue medications, side effects, and patient satisfaction. Participants will be randomly assigned to one of two groups: one group receives palonosetron before anesthesia begins and saline placebo at wound closure, while the other group receives saline placebo before anesthesia and granisetron at wound closure. Both groups will also receive dexamethasone as part of their antiemetic treatment. Standard anesthesia with remifentanil and propofol will be used, and morphine will be given before surgery ends for pain. During the study, nausea, vomiting, and retching will be monitored at 1, 4, 12, 24, and 48 hours after surgery. Researchers will evaluate the need for additional antiemetic drugs, any side effects from the study drugs, and patient satisfaction at 48 hours. The trial is double-blinded and randomized, with a total planned enrollment of 92 participants aged 10 years and older with idiopathic scoliosis.
CONDITIONS
Brief 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
You may qualify if you...
- Age 10 years and above
- American Society of Anesthesiologists (ASA) class I-II
- Diagnosed with idiopathic scoliosis and scheduled for posterior spinal fusion surgery
- Able to provide written informed consent or assent (with guardian consent for adolescents)
You will not qualify if you...
- Active smoker
- Obesity with body mass index (BMI) of 34 or above
- Body weight less than 30 kg
- History of gastro-esophageal reflux disease or other gastrointestinal conditions causing vomiting
- History of motion sickness
- Allergy to 5-HT3 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 > 430 ms in men or > 450 ms in women)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants receive either palonosetron or granisetron alongside dexamethasone during spine surgery under total intravenous anaesthesia. The medications are administered intravenously before or during surgery to help prevent postoperative nausea and vomiting.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 48 hours after surgery
Participants are monitored for postoperative nausea and vomiting, adverse effects, and satisfaction for 48 hours after surgery.
Multiple assessments at 1, 4, 12, 24, and 48 hours post-surgery
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
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Published Research Related To This Trial
Early post-operative nausea and vomiting: A retrospective observational study of 2030 patients.
Emma Johansson, Magnus Hultin, Tomi Myrberg...
https://pubmed.ncbi.nlm.nih.gov/34086350Adolescent idiopathic scoliosis.
Jack C Cheng, René M Castelein, Winnie C Chu...
https://pubmed.ncbi.nlm.nih.gov/27188385Propofol 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/30409186Total 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/27454663Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Tong J Gan, Kumar G Belani, Sergio Bergese...
https://pubmed.ncbi.nlm.nih.gov/32467512Effects 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/15915040Does 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