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Nasal Dexmedetomidine Pharmacokinetics in Infants undergoing cardiac catheterization

Nasal Dexmedetomidine Pharmacokinetics in Infants undergoing cardiac catheterization

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008589
Enrollment
Unknown
Registered
2016-06-03
Start date
2016-06-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

congenital heart disease

Interventions

Case series:single intranasal dose of 2.0 mcg/kg Dexmedetomidine

Sponsors

Guangzhou Women and Chindren's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Infants and children scheduled to receive sedation/anesthesia for cardiac catheterization; 2. The subject must be a candidate to receive 2.5 mcg/kg or 3.0 mcg/kg of dexmedetomidine. A staff member of the Division of Cardiac Anesthesiology will make this decision; 3. The subjects must be 3 months to 36 months (inclusive of the 36th month); The subjects legally authorized representative has given written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: PNA 36 months 1. The subject is allergic to or has a contraindication to dexmedetomidine; 2. Subjects with renal and liver disease; 3. ASA physical status >3; 4. Severely depressed ventricular function or cardiac output; 5. The subject has cardiac conduction system disease (e.g. 2nd degree AV block); 6. The subject has received digoxin or beta-adrenergic antagonist on the day of the study; 7. The subject has Trisomy 21 (exaggerated risk of bradycardia); 8. The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction).

Design outcomes

Primary

MeasureTime frame
the early pharmacokinetics of nasal dexmedetomidine;

Secondary

MeasureTime frame
occurrence rate of bradycardia;occurrence rate of hypertension;

Countries

China

Contacts

Public ContactBilian Li

Guangzhou Women and Chindren's Medical Center

13570226780@126.com+86 13570226780

Outcome results

None listed

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