Skip to content

Clinical study on the safety and effectiveness of anesthesia depth monitoring drug delivery system

Clinical study on the safety and effectiveness of anesthesia depth monitoring drug delivery system

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110214
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-03-11
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Patients undergoing non cardiac surgery requiring general anesthesia based on their condition (with an estimated surgery duration of less than 4 hours)

Interventions

The experimental group used the Yifei Huatong anesthesia depth monitoring drug delivery system for closed-loop automatic drug delivery:Closed loop automatic administration through the Yifei Huatong an
The control group received medication through traditional manual infusion method:Traditional manual infusion method for drug administration

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing non cardiac surgery requiring general anesthesia based on their condition (with an estimated surgery duration of less than 4 hours); 2. 18 <= Age <= 65; 3. American Society of Anesthesiologists (ASA) classification I-II; 4. 18.5 <= Body Mass Index BMI <= 28.0; 5. The patient agrees to participate in this trial, is willing to comply with the study requirements to complete all visits, and signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who are not suitable for surgery with electrodes attached to the forehead; 2.Patients with a history of using psychotropic drugs or alcohol dependence in the past; 3.Patients who are unable to communicate normally with researchers or complete the informed consent process; 4.Patients with cognitive impairment; 5.Pregnant and lactating women; 6.Patients with severe liver and kidney dysfunction (creatinine and urea nitrogen levels greater than 1.5 times normal); 7.Patients who have participated or are currently participating in other clinical trials within the past month; 8.Researchers believe that there are other situations that are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Anesthesia stability;Anesthesiologist workload;

Secondary

MeasureTime frame
The proportion of time required to maintain appropriate sedation effect;Body movement frequency;Intraoperative awareness of incidence rate;Comparison of sedative (propofol) dosage;Comparison of analgesic drug (remifentanil) dosage;Comparison of the dosage of sedatives (propofol) during induction period;Comparison of the dosage of induction phase analgesics (remifentanil);Heart rate stability;Wake up duration;

Countries

China

Contacts

Public ContactAnshi Wu

Beijing Chao-Yang Hospital, Capital Medical University

wuanshi88@163.com+86 10 8523 1325

Outcome results

None listed

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