How ciprofol behaves and affects older adults having limb surgery under general anesthesia

Population Pharmacokinetic/Pharmacodynamic Modeling of Ciprofol in Elderly Patients Undergoing Orthopedic Limb Surgery

This study tests whether ciprofol provides safe and effective anesthesia for older adults having elective limb surgery by measuring drug levels and clinical responses.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Shanghai Geriatric Medical Center (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07301242 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective observational project enrolling patients aged 65 and older who receive ciprofol as part of routine general anesthesia for elective orthopedic limb surgery. Participants will provide timed blood samples during and after surgery while researchers record vital signs, anesthesia dosing, recovery scores (such as the Aldrete score), and signs of postoperative delirium. Collected data will be used to build and validate a population pharmacokinetic/pharmacodynamic (PK/PD) model tailored to elderly orthopedic patients. The validated model aims to support target-controlled infusion (TCI) systems for more individualized intraoperative dosing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 or older with BMI 18–30 kg/m², ASA physical status I–III, scheduled for elective orthopedic limb surgery lasting more than 30 minutes, and able to give informed consent.

Not a fit: Patients younger than 65, those not receiving ciprofol, emergency surgery cases, or people with significant preoperative cognitive impairment or contraindications to ciprofol are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the generated PK/PD model could help clinicians use TCI to tailor ciprofol dosing in elderly patients and reduce risks of over- or under-dosing.

How similar studies have performed: Ciprofol has shown promising safety and efficacy in earlier trials mostly involving younger or healthier populations, but PK/PD models for elderly orthopedic patients remain limited, so applying these methods in this group is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥65 years;
* BMI: 18-30 kg/m²;
* ASA physical status classification I-III;
* Scheduled for elective orthopedic limb surgery under general anesthesia;
* Expected duration of surgery \>30 minutes;
* Willing to participate and able to provide written informed consent.

Exclusion Criteria:

* Known allergy to ciprofol or related medications, or any contraindication to their use;
* Preoperative cognitive impairment;
* History of severe cerebrovascular disease or related complications;
* History of neuromuscular system diseases or psychiatric disorders;
* History of sedative medication use;
* History of alcohol abuse or substance use disorder;
* Bradycardia (heart rate \<60 beats per minute);
* Hypotension (mean arterial pressure \<55 mmHg);
* QT interval prolongation;
* Uncooperative or unable to communicate effectively.

Where this trial is running

Shanghai

• Shanghai Geriatric Medical Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Xue Zhang — Shanghai Geriatric Medical Center
• Study coordinator: Xue Zhang

Conditions Hip Fractures; Osteoarthritis, Knee and Hip; Femoral Neck Fractures