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Appropriate Dosage of Vasopressor in Neonates and Infants
Sponsor: Seoul National University Hospital
Summary
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.
Official title: A Study on the Appropriate Dosage of Vasopressors to Maintain Adequate Cerebral Blood Flow During Surgery and Anesthesia in Neonates and Infants
Key Details
Gender
All
Age Range
Any - 2 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2024-02-15
Completion Date
2028-02-28
Last Updated
2024-02-15
Healthy Volunteers
No
Interventions
EPHEDrine Hydrochloride 5 mg/ml
In 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.