Cesarean Section, Intravenous, Lozenge, Ondansetron, Prevention, Shivering
Conditions
Brief summary
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).
Detailed description
Spinal anesthesia has many advantages when used for cesarean section (CS). It is a popular technique with rapid onset and high success rate. Shivering is associated with increased metabolic activity and consumption of oxygen. In addition, arterial hypoxia, lactic acidosis, and interference with electrocardiogram monitoring could be associated with shivering. 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. This medicine also decreases nausea and vomiting intra-and post-operatively.
Interventions
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Patients will receive 8 mg of ondansetron IV just before the surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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 cesarean section 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. * Preoperative shivering. * Preoperative fever (\>38°C). * Body mass index \> 40 kg/m2. * Medical history of alcohol or drug abuse. * Hypo- or hyperthyroidism. * Parkinson's disease or any extrapyramidal disease. * Intraoperative blood transfusion.
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 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). |
| Degree of patient 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). |
| Incidence of adverse effects | 24 hours postoperatively | Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded. |
Countries
Egypt
Contacts
CONTACTMohammed S Elsharkawy, MD
Outcome results
None listed