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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT04452656
Eligibility Criteria:
Inclusion Criteria:
* Age:6 months-7 years.
* ASA, American Society of Anesthesiology, II and III .
* Patients undergoing cardiac surgeries with midline sternotomy incision.
Exclusion Criteria:
* Patients whose parents or legal guardians refusing to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Known or suspected coagulopathy.
* Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
* Known or suspected allergy to any of the studied drugs.
* Elevated liver enzymes more than the normal values.
* Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
7 Years
Study:
NCT04452656
Study Brief:
Protocol Section:
NCT04452656