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RECRUITING
NCT07301242

Population Pharmacokinetics and Pharmacodynamics of Ciprofol

Sponsor: Shanghai Geriatric Medical Center

View on ClinicalTrials.gov

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.

Official title: Population Pharmacokinetic/Pharmacodynamic Modeling of Ciprofol in Elderly Patients Undergoing Orthopedic Limb Surgery

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-10-28

Completion Date

2026-12

Last Updated

2025-12-24

Healthy Volunteers

No

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.

Locations (1)

Shanghai Geriatric Medical Center

Shanghai, China