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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Hypotension

Study type: Observational

Funder types: Other

Identifiers

NCT05513066

2022 BONNIN ARTEMIS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Ephedrine/phenylephrine mixture

Description:

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

Description:

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.