Population Pharmacokinetics and Pharmacodynamics of Ciprofol

NCT07301242 | Recruiting FDA Drug

• 1 other identifier: ZCLY2025-021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Provide blood samples at different time points during and after surgery.
2. 2.Have their vital signs and anesthesia-related data recorded before, during, and after surgery.
3. 3.Be monitored for side effects and recovery indicators such as the Aldrete score and signs of postoperative delirium.
4. 4.Build and test a population PK/PD model for ciprofol.
5. 5.Simulate recommended TCI dosing plans.
6. 6.Explore how individual responses to ciprofol relate to recovery and safety outcomes.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  From the start of drug administration to 24 hours after the end of drug administration.

• 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.

  Continuously monitored from the start of anesthesia induction, throughout the maintenance phase, until full recovery (approximately up to 4 hours).

• 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.

  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 (2)

• Mean Arterial Pressure (MAP)

  Continuously measured during the induction, maintenance (intra-operative), and recovery phase (up to 2 hours post-infusion).

• Heart Rate

  Continuously measured during the induction, maintenance (intra-operative), and recovery phase (up to 2 hours post-infusion).

Study Arms (1)

Elderly Orthopedic Limb Surgery Cohort

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 (Mini-Cog score \<3); 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.

Drug: Ciprofol

Interventions

Ciprofol DRUG

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.

Also known as: Cipepofol, Sishuning

Elderly Orthopedic Limb Surgery Cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients undergoing orthopedic limb surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Geriatric Medical Center: lead

Study Sites (1)

Shanghai Geriatric Medical Center

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma samples will be retained for pharmacokinetic and pharmacodynamic analysis. No DNA extraction will be performed.

MeSH Terms

Conditions

Hip Fractures; Osteoarthritis; Femoral Neck Fractures

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Xue Zhang

  Shanghai Geriatric Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Zhang

CONTACT

02164175590; zx02190554@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 24, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)