NCT07301242 Population Pharmacokinetics and Pharmacodynamics of Ciprofol
| NCT ID | NCT07301242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Geriatric Medical Center |
| Condition | Hip Fractures (ICD-10 72.01-72.2) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-10-28 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Xue Zhang
PRINCIPAL INVESTIGATOR
Shanghai Geriatric Medical Center
Frequently Asked Questions
Who can join the NCT07301242 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Hip Fractures (ICD-10 72.01-72.2). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07301242 currently recruiting?
Yes, NCT07301242 is actively recruiting participants. Contact the research team at zx02190554@126.com for enrollment information.
Where is the NCT07301242 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07301242 clinical trial?
NCT07301242 is sponsored by Shanghai Geriatric Medical Center. The principal investigator is Xue Zhang at Shanghai Geriatric Medical Center. The trial plans to enroll 50 participants.