Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline

Study Overview
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Brief Summary
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Comparison of two practices of obstetrical services between the CHU of Clermont Ferrand and the HFME Lyon-Bron in the management of arterial hypotension during an elective cesarean section

Detailed Description
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The investigators propose to carry out a bicentric strict observational prospective study between the maternity of the HFME of Lyon-Bron which uses the mixture ephedrine / noradrenaline with the PSE for many years in service protocol for the management of hypotension for cesarean section under perimedullary anesthesia and the CHU of Clermont-Ferrand which uses baby noradrenaline 10 mcg/mL PSE for this same indication according to an institutional protocol. Patients corresponding to the inclusion and non-inclusion criteria will be recruited by a physician investigator and will give their agreement of non-opposition after having received clear oral and written information about our study. The care will not be modified in any way compared to the usual practices of the service.

Official Title
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Prospective, Observational and Bicentric Study of the Management of Arterial Hypotension During Planned Caesarean Section. Practice Comparison Between a Referral Center Using According to Service Protocol, an Intravenous Ephedrine/Phenylephrine Mixture at the PSE Versus Another Referral Center Using According to Service Protocol Intravenous Baby Noradrenaline

Conditions
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Hypotension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective caesarean ≥ 18 years old term ≥ 36 weeks amenorrhea Exclusion Criteria: contraindication of local anesthetics contraindication of spinal anesthesia patient's refusal patient doesn't talk French patient not covered by the social security system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ephedrine/phenylephrine mixture<br>10 mL of 0.75 mg/ml ephedrine and 10 mL of 37.5 μg/ml phenylephrine are mixed in a 20 mL syringe. The speed is generally started at 20 ml/h and then adapted according to blood pressure. | |
| baby noradrenaline<br>20 mL of baby norepinephrine 10µg/mL is prepared in a 50 mL syringe. The speed is generally started at 30 ml/h and then adapted according to blood pressure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Time-weighted mean intraoperative systolic blood pressure below a threshold of 80mmHg, 90mmHg and 100mmHg. This measurement is commonly called TWA (time weighted average), corresponding to the area between the chosen PAS threshold and the curve of the measured PAS, divided by the total time of the measurements. Blood pressure will be measured by the Clearsight system, absolutely non-invasive continuous pulse wave contour monitoring. | duration of the procedure up to one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sign of hypotension | nausea, vomiting, faint | duration of the procedure up to one hour | 
| Foetal pH | arterial and venous | at birth | 
| boli of vasopressor | appeal to boli of ephedrine and/or phenylephrine and/or noradrenaline | duration of the procedure up to one hour | 
| boli of atropine | appeal to boli of atropine | duration of the procedure up to one hour | 
| crystalloids | volume of crystalloids infused | duration of the procedure up to one hour | 
| total diuresis |  | duration of the procedure up to one hour | 
| intrathecal local anesthetics | amount of intrathecal local anesthetics injected | duration of the procedure up to one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean, spinal anesthesia, hypotension, norepinephrine, ephedrine, phenylephrine, sympathetic block