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

Tanta University

Status: Completed

Conditions: Cesarean Section; Ondansetron Lozenge; Post-Spinal Shivering

Treatments: Drug: Ondansetron lozenge

Study type: Interventional

Funder types: Other

Identifiers

NCT06423807

36264PR642/4/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group S (Ondansetron lozenge)

Experimental group

Description:

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

Treatment:

Drug: Ondansetron lozenge

Group C (Control)

No Intervention group

Description:

Patients will not receive ondansetron as a control group.