Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ondansetron lozenge, Ondansetron intravenous.
- Who it may be relevant to
- Registry conditions: Ondansetron, Lozenge, Intravenous, Prevention. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
Overview
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).
Detailed description
Spinal anesthesia has many advantages when used for cesarean section (CS). It is a popular technique with rapid onset and high success rate.
Shivering is associated with increased metabolic activity and consumption of oxygen. In addition, arterial hypoxia, lactic acidosis, and interference with electrocardiogram monitoring could be associated with shivering.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. This medicine also decreases nausea and vomiting intra-and post-operatively.
Interventions
- Drug Ondansetron lozenge
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. - Drug Ondansetron intravenous
Patients will receive 8 mg of ondansetron IV just before the surgery.
Primary outcome measures
- Incidence of shivering [Time frame: 24 hours postoperatively]
Secondary outcome measures (3)
- Incidence of postoperative nausea and vomiting [Time frame: 24 hours postoperatively]
- Degree of patient satisfaction [Time frame: 24 hours postoperatively]
- Incidence of adverse effects [Time frame: 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Age from 18 to 40 years.
- American Society of Anesthesiology (ASA) physical status II.
- Parturient women undergoing cesarean section 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.
- Preoperative shivering.
- Preoperative fever (>38°C).
- Body mass index > 40 kg/m2.
- Medical history of alcohol or drug abuse.
- Hypo- or hyperthyroidism.
- Parkinson's disease or any extrapyramidal disease.
- Intraoperative blood transfusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07511491 · 36264PR1310184/2/26