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BIS guided closed-loop target controlled infusion of propofol in children: a randomized controlled trail

BIS guided closed-loop target controlled infusion of propofol in children: a randomized controlled trail

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ICR-15007333
Enrollment
Unknown
Registered
2015-11-03
Start date
2015-11-04
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

General anesthesia in children

Interventions

1:BIS guided closed-loop target controlled infusion of propofol
2:BIS guided open-loop target controlled infusion of propofol

Sponsors

Capital Institute of Pediatrics
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Children scheduled to surgery under general anesthesia; 2. Aged 1 to 14 years old; 3. Expected surgery time about 1 to 3 hours; 4. ASA grade 1 or 2; 5. The parents agreed to take part in the trail and sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Children with respiratory, circulatory, hepatic, renal or metabolic disease; 2. Children with mental development disorders; 3. The body mass index (BMI) exceed 20% of the normal values; 4. The operation position unfit for BIS monitor; 5. The children with no introvenous access before the surgery.

Design outcomes

Primary

MeasureTime frame
Global Score;—

Secondary

MeasureTime frame
Percentage of time with BIS 40-60;MDPE;MDAPE;wobble;dose of propofol;time to extubation;time to eyes oenning;time to consciousness recovery;Heart rate;blood pressure;Bispectral index;—

Countries

China

Contacts

Public ContactPan Should-dong
adohn@163.com+86 13522736169

Outcome results

None listed

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