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Population Pharmacokinetics and Pharmacodynamics of Ciprofol

NCT07301242 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

  • Hip Fractures (ICD-10 72.01-72.2)
  • Osteoarthritis, Knee and Hip
  • Femoral Neck Fractures

Interventions

DRUG

Ciprofol

Ciprofol is used as an intravenous anesthetic agent for sedation and anesthesia induction/maintenance in elderly patients undergoing elective orthopedic limb surgery. In this observational study, ciprofol is administered according to standard clinical practices, and data on its pharmacokinetics, pharmacodynamics, safety, and effectiveness in this specific population will be collected.

Sponsors & Collaborators

  • Shanghai Geriatric Medical Center

    lead OTHER

Principal Investigators

  • Xue Zhang · Shanghai Geriatric Medical Center

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301242 on ClinicalTrials.gov