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Clinical Research and Evaluation of a closed-loop target controlled infusion system (SLG) for infusion of propofol guided by bispectral index (BIS)

Clinical Research and Evaluation of a closed-loop target controlled infusion system (SLG) for infusion of propofol guided by bispectral index (BIS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008138
Enrollment
Unknown
Registered
2016-03-22
Start date
2016-03-14
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

Interventions

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Informed consent; 2. Aged 18-75 years old, male or female; 3. ASA I~II; 4. BMI between 18kg/m2 to 30kg/m2; 5. Elective surger under general anesthesia, expected operation time of 120 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, liver function higher than 1.5 times the upper limit of normal; 9. Renal dysfunction, creatinine clearance 133µmol / L; 10. 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;

Secondary

MeasureTime frame
Satisfaction anesthesia 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