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Clinical trial

Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial

ID
Name
36264PR642/4/24
Description
The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.
Trial arms
Trial start
2024-05-21
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Ondansetron lozenge
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Arms:
Group S (Ondansetron lozenge)
Size
60
Primary endpoint
Incidence of shivering
24 hours postoperatively
Eligibility criteria
Inclusion Criteria: * Age from 18 to 40 years. * American Society of Anesthesiology (ASA) physical status II. * Parturient women undergoing CS under spinal anesthesia. Exclusion Criteria: * Parturient women with any contraindication or hypersensitivity to the study drugs. * Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial. * Temperature more than 38°C or less than 36°C. * Body Mass Index (BMI)\> 40 kg/m2. * Medical history of alcohol or drug abuse. * Parkinson's disease or any extrapyramidal disease. * Intraoperative blood transfusion. * History of chemotherapy treatment.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-05-22

1 organization

1 product

3 indications

Organization
Tanta University
Product
Ondansetron
Indication
Ondansetron Lozenge
Indication
Post-Spinal Shivering
Indication
c-section