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The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.
Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV).
PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost.
The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron lozenge (Ondalenz ©) | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| Ondansetron IV | Experimental | Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery. |
|
| Control group | No Intervention | Patients will not receive ondansetron as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron lozenge (Ondalenz ©) | Drug | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of postoperative nausea and vomiting (PONV) | Severity of postoperative nausea and vomiting will be scored at 0-4, 4-12, 12-24 hours using Nausea vomiting scores (NVS): [(0, No complaint; 1, Mild degree of nausea; 2, Moderate degree of nausea; 3, Frequent vomiting; 4, Severe vomiting (continuously)]. | 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
Women caesarean section
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| 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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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| Ondansetron IV | Drug | Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery. |
|
| Degree of patient 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). |
| 24 hours postoperatively |
| Adverse effects | Side effects including headache, dry mouth, dizziness, visual disturbances, agitation, and sedation, will be evaluated on admission to the post anesthesia care unit (PACU) until discharge from the hospital. | 24 hours postoperatively |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |