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The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.
Ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (SAIH) and norepinephrine requirement during caesarean section.
The mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the Bezold-Jarisch reflex, leading to vasodilation and hypotension. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are required for the activation of the Bezold-Jarisch reflex. In a rabbit model, a 5-HT3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the Bezold-Jarisch reflex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron (Zofran) | Active Comparator | Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot |
|
| Saline placebo | Placebo Comparator | Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron (Zofran) | Drug | Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of norepinephrine during the whole surgical procedure. | Comparison between total amount of vassopressor used to maintain normal blood pressure in both groups of study | Just after subarachnoid block till the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia). | Just after subarachnoid block till 24 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waleed T Farouk, Resident | Contact | +2001150903140 | Waleedtarek523@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed H Bakri, professor | Assiut University | Study Director |
| Ola M Wahba, A.professor | Assiut University | Study Director |
| Abdelrahman H Mohammed, A.professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Asyut | Egypt |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38000073 | Result | Sheng ZM, Sun HQ, Mao JQ, Liu J, Liang G, Mei Z. Comparative dose-response study on the infusion of norepinephrine combined with intravenous ondansetron versus placebo for preventing hypotension during spinal anesthesia for cesarean section: a randomised controlled trial. Int J Surg. 2024 Feb 1;110(2):832-838. doi: 10.1097/JS9.0000000000000920. |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Saline (NaCl 0,9 %) (placebo) | Drug | normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia |
|
| Assiut University |
| Study Director |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |