Population Pharmacokinetics and Pharmacodynamics of Ciprofol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorShanghai Geriatric Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥65 years;
BMI: 18-30 kg/m²;
ASA physical status classification I-III;
Scheduled for elective orthopedic limb surgery under general anesthesia;
Disqualifiers
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;
Trial population
Elderly patients undergoing orthopedic limb surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ciprofol
DrugCiprofol 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Elderly Orthopedic Limb Surgery Cohort1 intervention
Trial outcomes
Primary outcomes
1
Plasma Concentration of Ciprofol
Arterial or venous blood samples (1 mL each) will be collected to measure the plasma concentration of ciprofol using liquid chromatography - mass spectrometry. These concentration data points will be used to construct the population pharmacokinetic model. Reported in ng/mL.
Time frame
From the start of drug administration to 24 hours after the end of drug administration.2
Bispectral Index (BIS) Value
The BIS value is a non-invasive measure of the level of consciousness/depth of anesthesia, ranging from 0 (isoelectric EEG) to 100 (awake). It is used as the pharmacodynamic metric for modeling.
Time frame
Continuously monitored from the start of anesthesia induction, throughout the maintenance phase, until full recovery (approximately up to 4 hours).3
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
The MOAA/S scale is a categorical measure used to assess the depth of sedation/anesthesia. Scores range from 0 (No response to painful stimulus) to 5 (Responds readily to name spoken in normal tone). This metric will be used as a pharmacodynamic endpoint to construct a categorical PK/PD model (e.g., proportional odds model) relating ciprofol concentration to clinical sedation depth.
Time frame
Induction phase (every minute until loss of consciousness); Maintenance phase; and Post-operative phase (every 3 minutes in PACU until score returns to 5), up to approximately 4 hours.Secondary outcomes
1
Mean Arterial Pressure (MAP)
Evaluation of hemodynamic stability by measuring the absolute value of Mean Arterial Pressure. Reported in millimeters of mercury (mmHg).
Time frame
Continuously measured during the induction, maintenance (intra-operative), and recovery phase (up to 2 hours post-infusion).2
Heart Rate
Evaluation of hemodynamic stability by measuring the absolute value of Heart Rate. Reported in beats per minute (bpm).
Time frame
Continuously measured during the induction, maintenance (intra-operative), and recovery phase (up to 2 hours post-infusion).Sponsors and contacts
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Source ClinicalTrials.gov