Actively Recruiting
Population Pharmacokinetics and Pharmacodynamics of Ciprofol
Led by Shanghai Geriatric Medical Center · Updated on 2025-12-24
50
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to learn how the anesthetic drug ciprofol works in older adults who are having limb surgery under general anesthesia at Shanghai Geriatric Medical Center. The study will help researchers build a population model to better understand how the drug moves through the body (PK) and how it affects patients (PD). This model may help doctors use a Target-Controlled Infusion (TCI) system to adjust the drug dose more precisely. The main question it aims to answer is: Does ciprofol work safely and effectively in older adults during orthopedic surgery? Participants already receiving ciprofol as part of their regular anesthesia care will: 1. Provide blood samples at different time points during and after surgery. 2. Have their vital signs and anesthesia-related data recorded before, during, and after surgery. 3. Be monitored for side effects and recovery indicators such as the Aldrete score and signs of postoperative delirium. Researchers will use this information to: 1. Build and test a population PK/PD model for ciprofol. 2. Simulate recommended TCI dosing plans. 3. Explore how individual responses to ciprofol relate to recovery and safety outcomes. This study may help improve anesthesia care for elder adults by making drug dosing safer and more effective.
CONDITIONS
Official Title
Population Pharmacokinetics and Pharmacodynamics of Ciprofol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Body mass index (BMI) between 18 and 30 kg/m²
- ASA physical status classification I to III
- Scheduled for elective orthopedic limb surgery under general anesthesia
- Expected duration of surgery longer than 30 minutes
- Willing and able to provide written informed consent
You will not qualify if you...
- Known allergy to ciprofol or related medications or contraindications 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 with heart rate less than 60 beats per minute
- Hypotension with mean arterial pressure less than 55 mmHg
- QT interval prolongation
- Uncooperative or unable to communicate effectively
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Geriatric Medical Center
Shanghai, China
Actively Recruiting
Research Team
X
Xue Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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