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

• Conditions: Hypotension

• Registration Number: NCT05513066
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Study Start: 2022-09-02
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-12
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	duration of the procedure up to one hour	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France