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Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. (EPHEDRINE)

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ClinicalTrials.gov Identifier: NCT02384876
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The incidence of arterial hypotension under general anesthesia using sevoflurane is particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the initial mean blood pressure (mBP) is the definition of significant arterial hypotension in adults and children. In adults, intraoperative arterial hypotension is associated with an increase of intraoperative mortality and a certain neurological morbidity. In infants under 6 months of age, neurological disorders have been reported following general anesthesia. Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial hypotension.

Current management of hypotension uses vascular filling with crystalloids and vasopressive amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also be used. Ephedrine is particularly interesting because of its action on both α and β receptors and its mode of administration: one dose and peripheral access.

Only one study is available in children from birth to adulthood; it demonstrates a lower hemodynamic response in infants than in adults, when administered a low dose of Ephedrine (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses and the use of higher doses than those recommended.

The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine associated with a difference of proportion of newborns/infants in therapeutic success of 55%) compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative arterial hypotension.

Secondary objectives:

  • Return to a mBP superior to 38mmHg post Ephedrine administration.
  • To assess occurrence of hypoxemic events during anesthesia.
  • To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6 months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24 months.

Condition or disease Intervention/treatment Phase
Intraoperative Arterial Hypotension Infant, Newborn Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG. Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. A Randomized, Controlled, Open-label, Dose Escalation Study.
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG
Dose escalation: 6 successive cohorts with a maximal increasing dose
Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG
Active Comparator: Ephedrine, dose : 0.1 mg/kG, reference dose
Reference dose
Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.



Primary Outcome Measures :
  1. Therapeutic success is defined as a mBP superior to 80% of the basal mBP (prior to anesthesia) within 10 minutes post Ephedrine administration [ Time Frame: Continuous monitoring within 10 minutes post-administration ]

Secondary Outcome Measures :
  1. Return to a mBP superior to 38mmHg within 10 minutes post Ephedrine administration [ Time Frame: Continuous monitoring within 10 minutes post-administration ]
  2. Variations of O2 saturation in cerebral tissue (number of desaturations, evolution under treatment) using a Near Infrared Spectroscopy (NIRS) technology [ Time Frame: Continuous monitoring within 10 minutes post-administration ]
  3. Tolerance of Ephedrine: occurrence of serious adverse events [ Time Frame: During 3 days post-administration ]
    Clinical examination focusing specifically on heart rate and hypertension



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns or infants < 6 months of age,
  • boys and girls,
  • premature or not,
  • requiring general anesthesia induced by sevoflurane
  • who presents during anesthesia a decrease of blood pressure superior to 20% of the basal mBP (measured prior to surgery) despite of vascular filling with sodium chloride 0.9% (10mL/kg during 10 min).
  • Written, informed consent obtained from the 2 parents

Exclusion Criteria:

  • Allergy to Ephedrine.
  • Emergency surgery.
  • Patient having previously received other vasopressive amines.
  • Use of other indirect sympathomimetic drug such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate.
  • Premedication with clonidine
  • Congenital heart disease
  • IV-induced anesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384876


Contacts
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Contact: Mathilde de Queiroz Siqueira, MD 0472129756 ext +33
Contact: Segolene GAILLARD 04 72 35 75 51 ext +33 segolene.gaillard@chu-lyon.fr

Locations
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France
Hôpital d'Estaing Recruiting
Clermont-Ferrand, France, 63003
Contact: Jean-Etienne BAZIN         
Principal Investigator: Jean-Etienne BAZIN         
Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Mathilde DE QUEIROZ SIQUEIRA, MD    0472129756 ext +33    mathilde.de-queiroz-siqueira@chu-lyon.fr   
Hôpital Nord Recruiting
Saint Etienne, France, 42055
Contact: Serge Moliex         
Principal Investigator: Serge Moliex         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Mathilde de Queiroz Siqueira, MD Service d'anesthésie pédiatrique et obstétricale, Hôpital Femme Mère Enfant, 59 boulevard Pinel - 69 677 BRON Cedex

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02384876     History of Changes
Other Study ID Numbers: 69HCL14_0248
2014-004190-16 ( EudraCT Number )
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

Keywords provided by Hospices Civils de Lyon:
pediatric
intraoperative arterial hypotension
ephedrine
general anesthesia

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Hypotension
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Pseudoephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents