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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05513066
Acronym
ARTEMIS
Enrollment
300
Registered
2022-08-24
Start date
2022-09-02
Completion date
2024-02-01
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

cesarean, spinal anesthesia, hypotension, norepinephrine, ephedrine, phenylephrine, sympathetic block

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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressureduration of the procedure up to one hourTime-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

MeasureTime frameDescription
Foetal pHat birtharterial and venous
boli of vasopressorduration of the procedure up to one hourappeal to boli of ephedrine and/or phenylephrine and/or noradrenaline
boli of atropineduration of the procedure up to one hourappeal to boli of atropine
Clinical sign of hypotensionduration of the procedure up to one hournausea, vomiting, faint
total diuresisduration of the procedure up to one hour
intrathecal local anestheticsduration of the procedure up to one houramount of intrathecal local anesthetics injected
crystalloidsduration of the procedure up to one hourvolume of crystalloids infused

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026