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

Cesarean Section Clinical Trial

Official title:

Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423807
• Other study ID #: 36264PR642/4/24
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Mohammed S Elsharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of postoperative nausea and vomiting (PONV)	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
Secondary	Patients' 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
Secondary	Adverse effects	Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.	24 hours postoperatively