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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03668951
Eligibility Criteria:
Inclusion Criteria:
* Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery
* The subject must be a candidate to receive Dex as determined by one of the study cardiac anesthesiologists
* The attending cardiac anesthesiologists for the case and the Chief of Anesthesia Cardiac Anesthesia will concur with or veto this decision
* The subjects legally authorized representative has given written informed consent to participate in the study
Exclusion Criteria:
* Post-natal age less than 6 months
* The subject is allergic to or has had a contraindication to Dex
* Severely depressed ventricular function on preoperative echocardiogram
* The subject has a high risk of cardiac conduction system disease in the judgement of the attending anesthesiologist or cardiologist
* The subject has a hemodynamically significant aortic coarctation or other left heart outflow obstruction
* The subject has received digoxin, beta-adrenergic antagonist, or calcium channel antagonist on the day of surgery
* The subject has received Dex within 1 week of the study date
* Patients who are to receive intranasal Dex are excluded if they have nasal/respiratory symptoms, which in the opinion of the study anesthesiologist, may affect intranasal drug absorption
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
48 Months
Study:
NCT03668951
Study Brief:
Protocol Section:
NCT03668951