Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section

NCT06423807 | Completed

• 1 other identifier: 36264PR642/4/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.

Conditions

Ondansetron Lozenge; Post-Spinal 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. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby.

  24 hours postoperatively

Secondary Outcomes (3)

• Incidence of postoperative nausea and vomiting (PONV)

  24 hours postoperatively

• Patients' satisfaction

  24 hours postoperatively

• Adverse effects

  24 hours postoperatively

Study Arms (2)

Group S (Ondansetron lozenge)

EXPERIMENTAL

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

Drug: Ondansetron lozenge

Group C (Control)

NO INTERVENTION

Patients will not receive ondansetron as a control group.

Interventions

Ondansetron lozenge DRUG

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

Group S (Ondansetron lozenge)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Parturient women undergoing cesarean section under spinal anesthesia
• 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 CS 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.
• Temperature more than 38°C or less than 36°C.
• Body Mass Index (BMI)\> 40 kg/m2.
• Medical history of alcohol or drug abuse.
• Parkinson's disease or any extrapyramidal disease.
• Intraoperative blood transfusion.
• History of chemotherapy treatment.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Officials

• Mohammed S Elsharkawy, MD

  Faculty of Medicine Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• 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: May 16, 2024
• First Posted: May 21, 2024
• Study Start: May 21, 2024
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

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)