Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT00135668
Eligibility Criteria:
Inclusion Criteria:
Study subjects must meet all of the following criteria:
* Subject is less than 17 years of age
* Neonates must be full-term gestation and have a body weight of at least 2.5 kg
* Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization
* Duration of the subject's controlled hypotension is expected to be ≥ 2 hours
* Subject requires general anesthesia with endotracheal intubation
* Subject requires placement of intra-arterial line during the surgical or medical procedure
* The subject's parent or legal guardian gives permission (informed consent) and subject gives assent when appropriate.
Exclusion Criteria:
Subjects will be excluded if any of the following criteria exist:
* Subject has a known allergy to SNP
* Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes
* Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or procedures
* Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
* Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
* Subject is moribund (death likely to occur within 48 hours)
* Subject has a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT00135668
Study Brief:
Protocol Section:
NCT00135668