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A clinical validation study to evaluate the accuracy and safety of the target-controlled mode infusion model in the cyclopofol effect chamber in patients under general anesthesia for elective surgery.

A clinical validation study to evaluate the accuracy and safety of the target-controlled mode infusion model in the cyclopofol effect chamber in patients under general anesthesia for elective surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113270
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-11-27
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

None

Interventions

Cyclopofol 0.8µg/ml effect-site target-controlled concentration group:Anesthesia was induced with cyclopofol at a target effect-site concentration of 0.8µg/ml
Cyclopofol 0.6µg/ml effect-site target-controlled concentration group:Anesthesia was induced with cyclopofol at a target effect-site concentration of 0.6µg/ml
Cyclopofol 1.0µg/ml effect-site target-controlled concentration group:Anesthesia was induced with cyclopofol at a target effect-site concentration of 1.0µg/ml

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ASA I-III grade, aged 18-80 years old 2. Surgeries requiring the placement of artificial airways under general anesthesia (including nasopharyngeal ventilation ducts, laryngeal masks, and tracheal tubes) 3. The anesthesia method is total intravenous anesthesia 4. The expected operation duration is more than half an hour, and BIS monitoring can be achieved during the operation 5. Be willing to participate in this trial and sign a written informed consent form

Exclusion criteria

Exclusion criteria: 1. Allergic to the drugs related to the experiment 2. Central nervous system diseases, poor state of consciousness, brain surgery, surgery requiring nerve stimulation, or inability to monitor BIS during surgery 3. Before the operation, there are already or are expected to be significant conditions that may affect drug metabolism during the operation (including but not limited to: massive blood loss, hypothermia, heart failure, multiple organ failure, shock, rapid deterioration of liver and kidney functions, etc.) Sedatives such as midazolam, sevoflurane and dexmedetomidine were used during the induction and maintenance of anesthesia 5. The researchers believe there are other circumstances that make participation unsuitable

Design outcomes

Primary

MeasureTime frame
The CeLoC/CeRoC, Cp, Ke0 and actual values were calculated;

Secondary

MeasureTime frame
Incidence of bradycardia;Incidence of hypotension;Incidence of intraoperative awareness;Incidence of respiratory depression;Area under the blood pressure-time curve during drug administration;The quality of induction and maintenance of general anesthesia;

Countries

China

Contacts

Public ContactGuo Chen

West China Hospital of Sichuan University

grace_chenguo@hotmail.com+86 18980601577

Outcome results

None listed

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