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

Tanta University60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ondansetron Lozenge Post-Spinal Shivering Cesarean Section

Interventions

Ondansetron lozengeDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 24 hours postoperatively

Secondary Outcomes

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).

Time frame: 24 hours postoperatively

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).

Time frame: 24 hours postoperatively

Adverse effects

Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

Time frame: 24 hours postoperatively

Data from ClinicalTrials.gov

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