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

Not Applicable

Completed

• Conditions: Ondansetron Lozenge; Cesarean Section; Post-Spinal Shivering
• Interventions: Drug: Ondansetron lozenge

• Registration Number: NCT06423807
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.

Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.

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. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study Start: 2024-05-21
• Study First Posted: 2024-05-21
• Primary Completion: 2024-09-29
• Study Completion: 2024-09-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age from 18 to 40 years.
• American Society of Anesthesiology (ASA) physical status II.
• Parturient women undergoing CS 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.; 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.

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting (PONV)	24 hours postoperatively	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).
Patients' satisfaction	24 hours postoperatively	• 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).
Adverse effects	24 hours postoperatively	Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt