Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Tong J Gan, Kumar G Belani, Sergio Bergese...
https://pubmed.ncbi.nlm.nih.gov/32467512/Actively Recruiting
Led by University of Malaya · Updated on 2025-04-25
74
Participants Needed
2
Research Sites
8 weeks
Total Duration
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
A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
K
Kenlee Liew, MBBS
S
Siti Nadzrah Yunus, MAnaes, MBBS
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University of Malaya
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor