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
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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.
- 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 ]
- Return to a mBP superior to 38mmHg within 10 minutes post Ephedrine administration [ Time Frame: 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 [ Time Frame: Continuous monitoring within 10 minutes post-administration ]
- Tolerance of Ephedrine: occurrence of serious adverse events [ Time Frame: During 3 days post-administration ]Clinical examination focusing specifically on heart rate and hypertension
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
|Contact: Mathilde de Queiroz Siqueira, MD||0472129756 ext +33|
|Contact: Segolene GAILLARD||04 72 35 75 51 ext +email@example.com|
|Clermont-Ferrand, France, 63003|
|Contact: Jean-Etienne BAZIN|
|Principal Investigator: Jean-Etienne BAZIN|
|Hospices Civils de Lyon||Recruiting|
|Contact: Mathilde DE QUEIROZ SIQUEIRA, MD 0472129756 ext +33 firstname.lastname@example.org|
|Saint Etienne, France, 42055|
|Contact: Serge Moliex|
|Principal Investigator: Serge Moliex|
|Principal Investigator:||Mathilde de Queiroz Siqueira, MD||Service d'anesthésie pédiatrique et obstétricale, Hôpital Femme Mère Enfant, 59 boulevard Pinel - 69 677 BRON Cedex|