Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

NCT07511491 | Recruiting

• 1 other identifier: 36264PR1310184/2/26
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ondansetron; Lozenge; Intravenous; Prevention; Shivering; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Incidence of shivering

  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

  24 hours postoperatively

Secondary Outcomes (3)

• Incidence of postoperative nausea and vomiting

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

• Incidence of adverse effects

  24 hours postoperatively

Study Arms (3)

Group L

EXPERIMENTAL

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

Drug: Ondansetron lozenge

Group O

EXPERIMENTAL

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

Drug: Ondansetron intravenous

Group C

NO INTERVENTION

Patients will not receive ondansetron as a control group.

Interventions

Ondansetron intravenous DRUG

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

Group O

Ondansetron lozenge DRUG

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

Group L

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Parturient women undergoing cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 18 to 40 years.
• American Society of Anesthesiology (ASA) physical status II.
• Parturient women undergoing cesarean section under spinal anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 6, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)