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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2024-09-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ondansetron Lozenge Post-Spinal Shivering Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group S (Ondansetron lozenge)

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

Group Type EXPERIMENTAL

Ondansetron lozenge

Intervention Type DRUG

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

Group C (Control)

Patients will not receive ondansetron as a control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ondansetron lozenge

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No