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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Geriatric Medical Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Xue Zhang — Shanghai Geriatric Medical Center
• Study coordinator: Xue Zhang
• Email: zx02190554@126.com
• Phone: 02164175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.