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A clinical study on the protective effect of dexmedetomidine on central nervous injury during perioperative period in children with congenital heart diseases

A clinical study on the protective effect of dexmedetomidine on central nervous injury during perioperative period in children with congenital heart diseases

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028593
Enrollment
Unknown
Registered
2019-12-28
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central nervous injury during perioperative period

Interventions

Experimental group:Dexmedetomidine
Control group:Normal saline

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 3 Years

Inclusion criteria

Inclusion criteria: (1) Age: 1-3 years old; (2) The legal guardian or agent of the child agrees to participate in this study and signs an informed consent form; (3) The main preoperative diagnosis of the child is atrial septum defect or ventricular septum defect.

Exclusion criteria

Exclusion criteria: (1) The child has a family history of mental retardation or related diseases before surgery; (2) The child has a history of brain trauma; (3) The child has contraindications to dexmedetomidine; (4) Preoperative examinations show that the child has inflammation or infection and does not receive effective treatment; (5) The duration of cardiopulmonary bypass is less than 15 min or more than 75 min; (6) The duration of aortic cross-blocking is less than 10 minutes or more than 60 minutes; (7) The child is diagnosed preoperatively or postoperatively as severe pulmonary hypertension; (8) The child is identified to be combined with other cardiac or vascular malformations (except patent ductus arteriosus, patent foramen ovale, mild aortic insufficiency, mild tricuspid insufficiency, mild mitral insufficiency); (9) The child has perioperative complications that may affect the test results.

Design outcomes

Primary

MeasureTime frame
Perioperative serum (or plasma) s100 concentration;Perioperative serum (or plasma) NSE concentration level;

Secondary

MeasureTime frame
Perioperative serum (or plasma) inflammatory factors (interleukin 1,6 and TNF) levels.;Perioperative serum (or plasma) hormone (norepinephrine) concentration levels;Preschool Scale of Intelligence;

Countries

China

Contacts

Public ContactZhe Zhang

Fuwai Hospital, Chinese Academy of Medical Sciences

zhangzhe@fuwaihospital.org+8615601007601

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026