Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Prevention; Shivering; Ondansetron; Intravenous; Lozenge
• Intervention / Treatment: Drug: Ondansetron lozenge; Drug: Ondansetron intravenous

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg
      • Principal Investigator: Salma E Kandil, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group L; Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.	Drug: Ondansetron lozenge; Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
No Intervention: Group C; Patients will not receive ondansetron as a control group.
Experimental: Group O; Patients will receive 8 mg of ondansetron IV just before the surgery.	Drug: Ondansetron intravenous; Patients will receive 8 mg of ondansetron IV just before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Piloerection or peripheral vasoconstriction but no visible shivering; Muscular activity in only one muscle group; Muscular activity in more than one muscle group but not generalized shivering; Shivering involving the whole body	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	24 hours postoperatively
Incidence of adverse effects	Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.	24 hours postoperatively
Incidence of postoperative nausea and vomiting	The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 36264PR1310184/2/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No