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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S (Ondansetron lozenge) | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group. |
|
| Group C (Control) | No Intervention | Patients will not receive ondansetron as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron lozenge | Drug | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours postoperatively |
| Patients' satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
Parturient women undergoing cesarean section under spinal anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed S Elsharkawy, MD | Faculty of Medicine Tanta University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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• 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). |
| 24 hours postoperatively |
| Adverse effects | Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded. | 24 hours postoperatively |