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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model Development of Ciprofol

Population Pharmacokinetic/Pharmacodynamic Model Construction of Ciprofol for Target-Controlled Infusion (TCI) Guidance in Elderly Patients Undergoing Orthopedic Limb Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111404
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

None

Interventions

Observation group:None

Sponsors

Shanghai Geriatric Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 65 years; 2.Body Mass Index (BMI) 18–30 kg/m^2; 3.American Society of Anesthesiologists (ASA) Physical Status Classification I–III; 4.Scheduled orthopedic limb surgery under general anesthesia; 5.Expected duration of surgery > 30 minutes; 6.Voluntary participation and signing of a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Allergy to ciprofol, propofol, benzodiazepines, opioids, or neuromuscular blocking agents, or having contraindications to ciprofol use; 2.Preoperative cognitive impairment (Preoperative Mini-Mental State Examination (MMSE) score <= 27); 3.Complications (such as emotional disorders, speech impairment, etc.) following a history of severe cerebrovascular disease or craniocerebral trauma; 4.History of neuromuscular system diseases or mental illnesses; 5.History of taking sedatives or antidepressants; 6.History of alcoholism or drug abuse; 7.Bradycardia; 8.Hypotension; 9.Prolonged QT interval; 10.Patients who are uncooperative or unable to communicate.

Design outcomes

Primary

MeasureTime frame
Core Parameters of Pharmacokinetic (PK) and Pharmacodynamic (PD) Models;

Countries

China

Contacts

Public ContactFang Hao

Zhongshan Hospital, Fudan University, Shanghai Geriatric Medical Center

drfanghao@163.com+86 21 64041990

Outcome results

None listed

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