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The effect of real-time blood concentration analysis combined with propofol TCI on anesthesia effect: a single-center, prospective, interventional study

The effect of real-time blood concentration analysis combined with propofol TCI on anesthesia effect: a single-center, prospective, interventional study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109051
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

General anesthesia surgery

Interventions

TCI group (control group):Full-course TCI target-controlled infusion was administered, and the TCI parameters were adjusted according to vital signs
Real-time blood drug concentration monitoring group (intervention group):Blood drug concentration monitoring is conducted every 20 minutes, and the TCI parameters are adjusted based on the monitored b

Sponsors

Shanghai Fourth People's Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old, regardless of gender or ethnicity; 2.Patients who intend to undergo elective surgery under total intravenous general anesthesia; 3.ASA I-III Levels; 4.Expected surgery duration of no more than 2 hours; 5.Non-emergency inpatients with appropriate preoperative preparation; 6.Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are unable to communicate with severe hearing impairment, dementia, coma, language impairment, etc. before surgery; 2. Abnormal increase in liver and kidney function (AST, ALT, BUN, Cr) before surgery (3 times or more); 3. History of abnormal surgical anesthesia in the past; 4. Severe systemic diseases, including but not limited to: severe renal impairment (preoperative dialysis treatment); Severe hepatic impairment (Child-Pugh grade C); Severe heart disease, LVEF = IV); 5. Suffering from hypertension and poorly controlled, or systolic blood pressure > 180mmHg or diastolic blood pressure >100mmHg when entering the room; 6. History of severe neurological and psychiatric diseases in the past; 7. History of psychotropic substance abuse; 8. Patients who are allergic to soy or the test drug; 9. Patients in shock; 10. Pregnant or parturient; 11. Participated in other drug trials within three months; 12. Refusal to participate in this study; 13. Other situations that the investigator believes are not suitable for participating in this study (reasons need to be recorded);

Design outcomes

Primary

MeasureTime frame
Time from discontinuation to natural eye opening of the patient (unit: min);

Secondary

MeasureTime frame
Intraoperative hemodynamic stability;Acute postoperative complications (delirium, nausea and vomiting);Propofol consumption;Vasoactive drugs and antihypertensive drugs used;Incidence of adverse events;

Countries

Chinese

Contacts

Public ContactXiong Lize/Chen Guozhong

Shanghai Fourth People's Hospital Affiliated to Tongji University

86919424@qq.com+86 139 6078 9827

Outcome results

None listed

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