Ireland
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Recruiting Not applicable

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

NCT07511491 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-04-11
Last updated
2026-06-23

Condition(s) studied

OndansetronLozengeIntravenousPreventionShiveringCesarean Section

Investigational drug(s) / intervention(s)

Ondansetron lozenge →Ondansetron intravenous →

Ondansetron lozenge: Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

Ondansetron intravenous: Patients will receive 8 mg of ondansetron IV just before the surgery.

Study summary

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of shivering — 24 hours postoperatively
    Shivering will be graded during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan and Tsai and Chu. 0 No shivering 1. Piloerection or peripheral vasoconstriction but no visible shivering 2. Muscular activity in only one muscle group 3. Muscular activity in more than one muscle group but not generalized shivering 4. Shivering involving the whole body

Trial sites (1)

FacilityCityRegionStatus
Tanta University Tanta El-Gharbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511491 on ClinicalTrials.gov ↗ ← All trials in Egypt