A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Malaya
About this trial
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? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 10 years and above
American Society of Anesthesiologists (ASA) class I-II
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Palonosetron (Group P)
DrugGroup P will be receiving palonosetron 1.5mcg/kg before the commencement of general anaesthesia
Granisetron (Group G)
DrugGroup G participants will receive IV Granisetron 1mg at the start of wound closure
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Palonosetron Group (Group P)Experimental treatment 1 intervention
Group B: Granisetron Group (Group G)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative nausea and vomiting (PONV) delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients
To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia.
Time frame
At 1 hour after surgery2
Incidence of postoperative nausea and vomiting (PONV)
To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia.
Time frame
At 4 hours after surgery3
Incidence of postoperative nausea and vomiting (PONV)
To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia.
Time frame
At 12 hours after surgery4
Incidence of postoperative nausea and vomiting (PONV)
To compare the effectiveness of palonosetron and granisetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia.
Time frame
At 24 hours after surgerySecondary outcomes
1
To evaluate the need for rescue antiemetics among participants
Number of Participants Developing Postoperative Nausea Vomiting Requiring Rescue Antiemetic Within 48 hours After Surgery Any occurrence of severe nausea and retching with visual analogue scale score ≥4; and vomiting of 1 or more episodes will be treated with the rescue drug IV metoclopramide. For adolescent subjects (aged less than 18 years old), IV metoclopramide will be given at 0.2mg/kg, with a maximum dose of 10 mg intravenously up to 3 times per day. For adult patients (18 years old and above), IV metoclopramide 10mg will be given, up to 3 times per day. If there is any further occurrence of PONV within 8 hours of administration of IV metoclopramide, a second line of rescue antiemetic, IV Granisetron 1mg, will be administered to participants in both arms of the study. The administration of any rescue medications will be recorded and taken into account during data processing.
Time frame
At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery2
To evaluate the adverse effects related to the study drugs.
Number of Participants Developing Adverse Effects Related to the Study Drugs.
Time frame
At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery3
To assess the degree of participant's satisfaction.
Degree of patient satisfaction as represented on the Likert scale Selection of a number from a scale of 1 (least satisfied) to 5 (most satisfied)
Time frame
At 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov