Cesarean Section, Ondansetron Lozenge, Post-Spinal Shivering
Conditions
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.
Interventions
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed