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NOT YET RECRUITING
NCT06257316
PHASE4

Appropriate Dosage of Vasopressor in Neonates and Infants

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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

DRUG

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.