Establishment of pharmacokinetic model of sufentanil combined with dexmedetomidine in children and correlation analysis of adverse reactions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021918

Enrollment

Unknown

Registered

2019-03-16

Start date

2019-03-20

Completion date

Unknown

Last updated

2019-03-18

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

Conditions

children‘s ’congenital heart disease

Interventions

1:Sufentanil+propofol

2:Sufentanil+Dexmedetomidine

Eligibility

Sex/Gender

All

Age

No minimum to 6 Years

Inclusion criteria

Inclusion criteria: (1) Patients are diagnosed as congenital heart disease; (2) Heart interventional therapy was planned under general anesthesia; (3) Children age 3 months to 72 months; (4) ASA level II-III.

Exclusion criteria

Exclusion criteria: (1) Abnormal liver and kidney function; (2) Allergic reaction to sufentanil or dexmedetomidine; (3) Patients with hematology, endocrine, metabolic or gastrointestinal diseases; (4) Long-term use of opioids or sedative-hypnotic drugs; (5) Have used µ receptor agonist or antagonist, alpha 2 receptor agonist or antagonist or other sedative drugs within 24 hours.

Design outcomes

Primary

Measure	Time frame
Drug concentration of sufentanil;	—

Secondary

Measure	Time frame
height;weight;blood pressure;heart rate;	—

Countries

China

Contacts

Public ContactBilian Li

Guangzhou Women and Children's Medical Centre

13570226780@126.com+86 13570226780

Outcome results

None listed

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