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Clinical study on the safety and efficacy of closed-loop target controlled infusion system for infusion of propofol guided by bispectral index (BIS) in general anesthesia of thoracic and abdominal surgery

Clinical study on the safety and efficacy of closed-loop target controlled infusion system for infusion of propofol guided by bispectral index (BIS) in general anesthesia of thoracic and abdominal surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014959
Enrollment
Unknown
Registered
2018-02-25
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-03-05

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

Conditions

general anesthesia

Interventions

closed-loop group:closed-loop target controlled infusion of propofol guided by bispectral index (BIS)
open-loop group:open-loop target controlled infusion of propofol guided by bispectral index (BIS)

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent; 2. Aged 18~65 years old, male or female; 3. ASA I~II; 4. BMI between 18kg/m2 to 30kg/m2; 5. Elective thoracic or abdominal surger under general anesthesia, expected operation time of 90 minutes or more.

Exclusion criteria

Exclusion criteria: 1. The central nervous system disease; 2. Using any drugs known to affect EEG preoperative such as antipsychotics, sedatives, anti-epileptic drugs, central nervous system stimulants, including alcohol; 3. Allergy to any ingredient of propofol and remifentanil; 4. The emergency surgery; 5. Implanted electronic devices, for example, a patient fitted with a pacemaker, etc; 6. Pregnant women and lactating women; 7. Serious cardiovascular, respiratory, kidney or muscle disease history; 8. Abnormal liver function,Renal dysfunction,Coagulation dysfunction; 9. Inappropriately controlled or difficult to controlled hypertension: non-invasive systolic blood pressure (SBP) >=160mmHg or non-invasive diastolic blood pressure (DBP) >=100mmHg.

Design outcomes

Primary

MeasureTime frame
global score;The percentage of Satisfaction anesthesia time;The percentage of too deep anesthesia time;The percentage of too shallow anesthesia time;The hemodynamic status during anesthesia induces and maintains;

Secondary

MeasureTime frame
Induction completion time;Wake up time;

Countries

China

Contacts

Public ContactMingzhang Zuo

Beijing Hospital

zuomz@163.com+86 010-85137596

Outcome results

None listed

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