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Population Pharmacokinetics and Pharmacodynamics of Ciprofol

Recruitingn/aAges 65 Years - anyAllShanghai Geriatric Medical Center
NCT07301242 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ind

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📋 Eligibility rules (as published)
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.
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What it tests

  • Ciprofol
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Where

1 site
Shanghai Geriatric Medical Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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