Actively Recruiting
Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
Led by Tanta University · Updated on 2026-04-14
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ondansetron lozenge compared to intravenous ondansetron for preventing shivering in women undergoing cesarean section with spinal anesthesia. Shivering during or after surgery can increase oxygen use and cause complications like arterial hypoxia and interference with heart monitoring. Ondansetron, a selective antagonist for 5-hydroxytryptamine 3 receptors, is studied for its ability to prevent shivering and reduce nausea and vomiting during and after surgery. The study involves three groups: one receiving a 4 mg ondansetron lozenge two hours before surgery, another receiving 8 mg of ondansetron intravenously just before surgery, and a control group receiving no ondansetron. This randomized trial compares these approaches to assess their impact on shivering prevention during cesarean section. Participants will be monitored for shivering incidence, nausea and vomiting, patient satisfaction, and any adverse effects within 24 hours after surgery. Researchers will collect data during this postoperative period to evaluate the treatments' effects. The study includes women aged 18 to 40 undergoing cesarean section under spinal anesthesia, with assessments focused on safety and symptom control during the first day after surgery.
CONDITIONS
Brief Title
Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 40 years.
- American Society of Anesthesiology (ASA) physical status II.
- Parturient women undergoing cesarean section under spinal anesthesia.
You will not qualify if you...
- Parturient women with any contraindication or hypersensitivity to the study drugs.
- History of cardiovascular diseases, psychosis, hypertension, fetal distress, or cord prolapse.
- Preoperative shivering.
- Preoperative fever (above 386C).
- Body mass index greater than 40 kg/m2.
- Medical history of alcohol or drug abuse.
- Hypothyroidism or hyperthyroidism.
- Parkinson's disease or any extrapyramidal disease.
- Intraoperative blood transfusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
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 ondansetron either as a lozenge 2 hours before surgery, intravenously just before surgery, or no ondansetron if assigned to the control group during cesarean section under spinal anesthesia.
1 visit (in-person)
Duration - 24 hours postoperatively
Participants are monitored for shivering, nausea, vomiting, satisfaction, and adverse effects for 24 hours after surgery.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
M
Mohammed S Elsharkawy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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