Appropriate Dosage of Vasopressor in Neonates and Infants

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the appropriate dosage of a medication called ephedrine, which is used to help raise blood pressure, in newborns and infants who are undergoing surgery. The researchers want to understand how to best maintain healthy blood flow to the brain during these procedures. They will do this by using ultrasound to check blood flow before and after giving the medication. This trial aims to find out the best blood pressure levels and dosages of ephedrine that will keep these young patients safe during surgery.

To qualify for this study, babies and infants under 2 years old who are scheduled for surgery at Seoul National University Hospital may be eligible. However, certain groups, like premature infants or those with specific health issues (such as certain heart conditions or brain diseases), cannot participate. If your child is selected for this trial, they will receive careful monitoring and care as part of the surgical process. It’s important to know that this trial is not yet recruiting participants, but it aims to gather valuable information that could improve surgical care for young children in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newborns and infants under 2 years of age undergoing surgery under general anesthesia at Seoul National University Hospital
• Exclusion Criteria:
• • 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
• • Children with uncorrected congenital cardiac malformations such as patent ductus arteriosus
• • Patients with hypersensitivity to ephedrine and its components
• • Patients with hypertension
• • Patients with thyrotoxicosis
• • Patients with renal impairment and those taking thyroid medication
• • Glaucoma patients
• • Diabetic patients
• • Patients with prostatic hyperplasia
• • Patients with chromophobe cell tumors
• • Patients taking or within 2 weeks of discontinuing monoamine oxidase inhibitors
• • Patients with ischemic heart disease
• • Patients receiving foxglove preparations
• • Patients with cardiac disease
• • Patients receiving inotropic agents and those with abnormal baseline blood pressure
• • Those who are taking or need to take concomitant contraindicated medications
• • Those who require halogenated anesthetics such as chloroform, cyclopropane, and halothane because concomitant administration may cause ventricular arrhythmias.
• • Those who are expected to require these agents because they may cause arrhythmias or cardiac arrest when coadministered with catecholamines such as epinephrine and isoproterenol.