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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004190-16 | EudraCT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG | Experimental | Dose escalation: 6 successive cohorts with a maximal increasing dose |
|
| Ephedrine, dose : 0.1 mg/kG, reference dose | Active Comparator | Reference dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic success is defined as a mBP superior to 55% of the basal mBP (prior to anesthesia) within 10 minutes post Ephedrine administration | Continuous monitoring within 10 minutes post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| Return to a mBP superior to 38mmHg within 10 minutes post Ephedrine administration | Continuous monitoring within 10 minutes post-administration | |
| Variations of O2 saturation in cerebral tissue (number of desaturations, evolution under treatment) using a Near Infrared Spectroscopy (NIRS) technology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde de Queiroz Siqueira, MD | Service d'anesthésie pédiatrique et obstétricale, Hôpital Femme Mère Enfant, 59 boulevard Pinel - 69 677 BRON Cedex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Estaing | Clermont-Ferrand | 63003 | France | |||
| Hospices Civils de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36639328 | Result | Szostek AS, Saunier C, Elsensohn MH, Boucher P, Merquiol F, Gerst A, Portefaix A, Chassard D, De Queiroz Siqueira M. Effective dose of ephedrine for treatment of hypotension after induction of general anaesthesia in neonates and infants less than 6 months of age: a multicentre randomised, controlled, open label, dose escalation trial. Br J Anaesth. 2023 May;130(5):603-610. doi: 10.1016/j.bja.2022.12.006. Epub 2023 Jan 12. | |
| 33712076 |
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| Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG. |
| Drug |
|
| Continuous monitoring within 10 minutes post-administration |
| Tolerance of Ephedrine: occurrence of serious adverse events | Clinical examination focusing specifically on heart rate and hypertension | During 3 days post-administration |
| Lyon |
| France |
| Hôpital Nord | Saint-Etienne | 42055 | France |
| Derived |
| Szostek AS, Boucher P, Subtil F, Zerzaihi O, Saunier C, de Queiroz Siqueira M, Merquiol F, Martin P, Granier M, Gerst A, Lambert A, Storme T, Chassard D, Nony P, Kassai B, Gaillard S. Determination of the optimal dose of ephedrine in the treatment of arterial hypotension due to general anesthesia in neonates and infants below 6 months old: the ephedrine study protocol for a randomized, open-label, controlled, dose escalation trial. Trials. 2021 Mar 12;22(1):208. doi: 10.1186/s13063-021-05155-2. |
| ID | Term |
|---|---|
| D004809 | Ephedrine |
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D006298 | Health Services Administration |
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