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Analysing Safty and Advantages of Using TIVA Triple Channel Automatic Infusion System, Concert-CL, with Monitoring in Preschool Children

Application of Closed-Loop control of Propofol TCI guided by BIS for Preschool Children: a radomized, controlled, multicenter clinical trail to evaluate the CONCERT-CL Closed-Loop System

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011433
Enrollment
Unknown
Registered
2017-05-18
Start date
2017-05-01
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

general anesthesia

Interventions

Two groups:Experimental group: closed-loop infusion of propofol in general anesthesia

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. General anesthesia; 2. Expected operation time is longer than 60 minutes; 3. Aged from 1 to 6 years old; 4. BMI within 20% of the standard range; 5. ASA I-II; 6. Obtain informed consent.

Exclusion criteria

Exclusion criteria: 1. Spirit syseem disease; 2. Central and peripheral nervous system disorders; 3. Neuromuscular system disorders; 4. Cerebral nerve surgery; 5. Hepatorenal and kidney function, 2 times abnormal blood coagulation or above; 6. Surgical position not suitable for BIS and TOF monitor 7. Hemodilution or hypothermia.

Design outcomes

Primary

MeasureTime frame
the proportion of time of adequate anesthesia;—

Countries

China

Contacts

Public ContactJianMin Zhang

Beijing Children's Hospital, Capital Medical University

zjm428@sina.com13910299602

Outcome results

None listed

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