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Population Total and Unbound Pharmacokinetics and Pharmacodynamics Modeling of a Novel Anaesthetic- Ciprofol and Its Major Glucuronide Metabolite, M4, in Chinse Patients with Kidney Injury and Tumors

Population Total and Unbound Pharmacokinetics and Pharmacodynamics Modeling of a Novel Anaesthetic- Ciprofol and Its Major Glucuronide Metabolite, M4, in Chinse Patients with Kidney Injury and Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064917
Enrollment
Unknown
Registered
2022-10-21
Start date
2022-10-21
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant tumor

Interventions

Group 1:

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. No restrictions,on gender, age or race;; 2. Patients who are diagnosed with cancer after pathological diagnosis; 3. Laboratory physical examination results or abnormal laboratory examination results with no clinical significance; 4. Comply with the principle of informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known sensitivity to excipients in Ciprofol injectable emulsion; history of drug allergies (including other anesthetics); 2. Patient having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents; 3. History or evidence of any one of the following diseases prior to screening/enrollment: History of cardiovascular diseases; respiratory insufficiency; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; history of mental illness: schizophrenia; 4. Any medication that has the potential to interact synergistically with Ciprofol, including but not limited to all sedatives and hypnotics; 5. Any condition, which in the investigator's opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study.

Design outcomes

Primary

MeasureTime frame
Plasma Ciprofol concentration;Plasma M4 concentration;Bispectrum Index, BIS ;

Countries

China

Contacts

Public ContactXin Tian

The First Affiliated Hospital of Zhengzhou University

tianx@zzu.edu.cn+86 13903830361

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026