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This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| Group O | Experimental | Patients will receive 8 mg of ondansetron IV just before the surgery. |
|
| Group C | 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
| 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 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 |
| Degree of patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
Parturient women undergoing cesarean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed S Elsharkawy, MD | Contact | 00201148207870 | mselsharkawy@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | 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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| Ondansetron intravenous | Drug | Patients will receive 8 mg of ondansetron IV just before the surgery. |
|
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 |
| Incidence of adverse effects | Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded. | 24 hours postoperatively |