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Utilization of a Closed-loop control System for Propofol TCI: A Prospective, Cohort Study

Utilization of a Closed-loop control System for Propofol TCI: A Prospective, Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-15007128
Enrollment
Unknown
Registered
2015-09-24
Start date
2015-10-01
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 anaesthesia for laparotomy

Interventions

closed-loop control group:closed-loop control of propol infusion guided by BIS

Sponsors

Anaesthesia Department, Westchina Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged between 18 to 65 years; 2. ASA grade level I ~ III; 3. estimated operation time >=2 hours.

Exclusion criteria

Exclusion criteria: 1. Comorbidity of cerebrovascular epilepsy or other neurological diseases; 2. have mental illness, recent psychiatric drug therapy; 3. with alcohol, opioids or other psychotropic substance abuse history; 4. difficult airway risks exist or for any other reason, can not receive conventional intravenous induce; 5. propofol allergy; 6. severe cardiovascular disease, liver andkidney function was abnormal; 7. albumin level abnormal; 8. BMI=30; 9. can not provide informed consent; 10. drug use of liver enzyme inducers or inhibitors one month preoperative. Common hepatic drug metabolizing enzyme inducers including barbiturates, carbamazepine, rifampicin, dexamethasone, ethanol (chronic alcoholism), griseofulvin, phenytoin class; common hepatic drug metabolizing enzyme inhibitors including chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid andsulfa drugs.

Design outcomes

Primary

MeasureTime frame
Propofol dosage during anesthesia maitenance period;UGT1A9 1399C> T andCYP2B6c.516G> T single nucleotide polymorphism;

Secondary

MeasureTime frame
propofol dosage required to reach a BIS level below 60 during induction period;percent of maitanence time with BIS value between 40 to 60;interval from stopping using propofol to opening eyes andextubation;dosage of remifentanyl during maintenance period;Perioperative hemodynamic andvasoactive drug use;The performance parameters of the closed-loop control system (performance error, median performance error, median absolute performance error, wobble andGS);incidence of intraoperative awareness andother serious adverse events;

Countries

China

Contacts

Public ContactZuo Yunxia
769574913@qq.com+86 13018200613

Outcome results

None listed

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