Appropriate Dosage of Vasopressor in Neonates and Infants
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorSeoul National University Hospital
About this trial
In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newborns and infants under 2 years of age undergoing surgery under general anesthesia at Seoul National University Hospital
Disqualifiers
Premature infants with a gestational age of less than 37 weeks
Children with a history of brain disease (hydrocephalus, brain tumor, etc.)
Patients with a history of hypoxic/ischemic brain injury
Children with fused fontanels
Trial design
Design model
Sequential
Treatments tested in this trial
EPHEDrine Hydrochloride 5 mg/ml
DrugIn the present study, the expected rate of recovery of the internal carotid artery according to the dose of the inotropic agent was similar to that in a previous study in which the fraction maintaining mean arterial pressure within 80% of baseline by dose of inotropic agent was 0.9% for the ephedrine 0.1, 0.6, 0.8, 1. 0, 1.2, and 1.4 doses (mg/kg) were 9.9%, 21%, 41%, 47%, 65.5%, and 40%, respectively (Br J Anaesth. 2023 May;130(5):603-610), and it was assumed that the rate of internal carotid artery recovery by inotrope dose would be 90% of that result. The study will randomize to dose in six cohorts and will include dose group and cohort variables in a logistic regression model to assess the trend between inotropic dose and rate of carotid revascularization after correcting for cohort effects on the outcome variable.
Treatment groups
132 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 0.1mg/kg of ephedrineActive comparator 1 intervention
Group B: 0.2mg/kg of ephedrineActive comparator 1 intervention
Group C: 0.3mg/kg of ephedrineActive comparator 1 intervention
Group D: 0.5mg/kg of ephedrineActive comparator 1 intervention
Group E: 1.0mg/kg of ephedrineActive comparator 1 intervention
Group F: 1.2mg/kg of ephedrineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recovery of cerebral blood flow within 10 minutes
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 10 minutes of the bolus injection.
Time frame
within 10 minutes after ephedrine injectionSecondary outcomes
1
Recovery of cerebral blood flow within 2 minutes
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 2 minutes of the bolus injection.
Time frame
within 2 minutes after ephedrine injection2
Recovery of cerebral blood flow within 5 minutes
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 5 minutes of the bolus injection.
Time frame
within 5 minutes after ephedrine injection3
Recovery of mean arterial pressure within 10 minutes
Whether the mean arterial pressure recovers to at least 80% of the baseline value within 10 minutes of the bolus injection.
Time frame
within 10 minutes after ephedrine injection4
Additional durg dose
Type and dose of additional inotropes administered if mean arterial pressure does not return to at least 80% of baseline within 10 minutes of ephedrine injection.
Time frame
within 10 minutes after ephedrine injectionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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