Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section

Study Overview
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Brief Summary
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The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP). The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates. It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant. One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses. The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section. The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.

Official Title
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Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study

Conditions
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Hypotension

Intervention / Treatment
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* Procedure: Spinal anaesthesia
* Drug: Ondansetron
* Other: saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons who have provided written informed consent Persons with national health insurance cover Patients aged over 18 years, ASA I or II About to undergo scheduled or non-scheduled caesarean section under spinal anaesthesia Exclusion Criteria: Adults under guardianship Contra indication for spinal anaesthesia (SA) (refusal, haemodynamic instability, innate or acquired coagulation disorder) History of hypersensitivity to Zophren or local anaesthetics Heart and/or kidney failure Treatment with angiotensin converting enzyme (ACE) inhibitor, Beta Blockers, or angiotensin II receptor antagonist (ARA II), Zophren, atropine, Selective Serotonin Reuptake Inhibitors, Triptans Caesarean in a context of extreme emergency, with a time to foetal extraction incompatible with SA and the injection of Zophren, (up to 30 minutes) and requiring consent in an emergency. Pregnancy-related arterial hypertension (AHT) Pre-eclampsia Gestational diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br> | Procedure: Spinal anaesthesia<br> <br> Drug: Ondansetron<br> <br> |
| Placebo Comparator: Saline solution<br> | Procedure: Spinal anaesthesia<br> <br> Other: saline solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of Systolic blood pressure below 90 mmHg |  | every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal anaesthesia