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HypotensionARTEMISNCT05513066

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

An observational study of Hypotension, run by University Hospital, Clermont-Ferrand at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hypotension
Type of treatment
Injection or infusion
How many people
300 participants
Where
2 sitesFrance
Study dates
2 Sep 2022to 1 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients are included on their entry in the obstetrical operating room during an elective caesarean section if they meet the inclusion and exclusion criteria. The investigating doctor informs them of the terms of our purely observational research study before the intervention and asks them for their oral agreement. The study treatment administered depends on the protocol of the center in which they are included.

Who may be able to join

  • elective caesarean
  • ≥ 18 years old
  • term ≥ 36 weeks amenorrhea

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Lise Laclautre contact

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

France2 sites, 2 recruiting

  • CHU clermont-ferrand

    Clermont-Ferrand

    Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr

    Martine BONNIN

    Recruiting

  • Hospices Civils de Lyon

    Lyon

    Lionel BOUVET

    Recruiting

Other trials in France

About this study

Official title: 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

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

Read the 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.

Conditions
Hypotension
Keywords
cesarean, spinal anesthesia, hypotension, norepinephrine, ephedrine, phenylephrine, sympathetic block
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05513066
Study groupRoleWhat they receive
Ephedrine/phenylephrine mixture10 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 noradrenaline20 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: duration of the procedure up to one hour

Secondary outcomes (7)

  1. Clinical sign of hypotension

    nausea, vomiting, faint

    Measured: duration of the procedure up to one hour

  2. Foetal pH

    arterial and venous

    Measured: at birth

  3. boli of vasopressor

    appeal to boli of ephedrine and/or phenylephrine and/or noradrenaline

    Measured: duration of the procedure up to one hour

  4. boli of atropine

    appeal to boli of atropine

    Measured: duration of the procedure up to one hour

  5. crystalloids

    volume of crystalloids infused

    Measured: duration of the procedure up to one hour

  6. total diuresis

    Measured: duration of the procedure up to one hour

  7. intrathecal local anesthetics

    amount of intrathecal local anesthetics injected

    Measured: duration of the procedure up to one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start2 Sep 2022
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513066
Sponsor's protocol ID
2022 BONNIN ARTEMIS
Acronym
ARTEMIS
Status last verified
Aug 2022
First submitted
19 Aug 2022
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.

    PubMed 11916798

  • Lim G, Facco FL, Nathan N, Waters JH, Wong CA, Eltzschig HK. A Review of the Impact of Obstetric Anesthesia on Maternal and Neonatal Outcomes. Anesthesiology. 2018 Jul;129(1):192-215. doi: 10.1097/ALN.0000000000002182.

    PubMed 29561267

  • Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.

    PubMed 27720613

  • Yousif D, Bellos I, Penzlin AI, Hijazi MM, Illigens BM, Pinter A, Siepmann T. Autonomic Dysfunction in Preeclampsia: A Systematic Review. Front Neurol. 2019 Aug 6;10:816. doi: 10.3389/fneur.2019.00816. eCollection 2019.

    PubMed 31447757

  • Juri T, Suehiro K, Kimura A, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Impact of non-invasive continuous blood pressure monitoring on maternal hypotension during cesarean delivery: a randomized-controlled study. J Anesth. 2018 Dec;32(6):822-830. doi: 10.1007/s00540-018-2560-2. Epub 2018 Sep 28.

    PubMed 30267340

  • Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

    PubMed 29090733

  • Hollmen AI, Jouppila R, Koivisto M, Maatta L, Pihlajaniemi R, Puukka M, Rantakyla P. Neurologic activity of infants following anesthesia for cesarean section. Anesthesiology. 1978 May;48(5):350-6. doi: 10.1097/00000542-197805000-00009.

    PubMed 646154

  • Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.

    PubMed 25654435

  • Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.

    PubMed 34034957

  • Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

    PubMed 25635593

  • Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x.

    PubMed 7091625

  • Sklebar I, Bujas T, Habek D. SPINAL ANAESTHESIA-INDUCED HYPOTENSION IN OBSTETRICS: PREVENTION AND THERAPY. Acta Clin Croat. 2019 Jun;58(Suppl 1):90-95. doi: 10.20471/acc.2019.58.s1.13.

    PubMed 31741565

  • Singh PM, Singh NP, Reschke M, Ngan Kee WD, Palanisamy A, Monks DT. Vasopressor drugs for the prevention and treatment of hypotension during neuraxial anaesthesia for Caesarean delivery: a Bayesian network meta-analysis of fetal and maternal outcomes. Br J Anaesth. 2020 Mar;124(3):e95-e107. doi: 10.1016/j.bja.2019.09.045. Epub 2019 Dec 4.

    PubMed 31810562

Questions about this trial

What is this clinical trial studying?

An observational study of Hypotension, run by University Hospital, Clermont-Ferrand at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood pressure (time frame: duration of the procedure up to one hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513066, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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