A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery

NCT06740201 | Recruiting Phase 4

• 1 other identifier: HSK3486-408
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multi-center (each center independently conducts the study according to the same research protocol), randomized, and open-label clinical study. The main objective is to verify and optimize the accuracy of the target-controlled infusion model of cipepofol.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Optimize the parameters CeLoC/CeRoC and Ke0 of the target-controlled infusion model of cipepofol.

  Calculate/record the effect-site concentrations of ciprofol (CeLoC/CeRoC) at the time of loss of consciousness (LoC) and recovery of consciousness (RoC), as well as the effect-site equilibrium rate constant (Ke0). The units of CeLoc and CeRoc is μg/ml. Calculate Ke0 through computer simulation based on the pharmacokinetic parameters.

  2 h

Study Arms (2)

Cp=0.9μg/ml

EXPERIMENTAL

Plasma target-controlled concentration 0.9μg/ml

Drug: Cipepofol

Cp=1.2μg/ml

EXPERIMENTAL

Plasma target-controlled concentration 1.2μg/ml

Drug: Cipepofol

Interventions

Cipepofol DRUG

Adjust plasma target-controlled concentration

Also known as: HSK3486

Cp=0.9μg/ml; Cp=1.2μg/ml

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient patients scheduled for elective surgeries that require tracheal intubation under general anesthesia, with the expected duration of surgery being ≥ 1 hour, excluding those in emergency, cardiothoracic, or neurosurgery departments (patients whose planned surgical types may affect the collection of the Bispectral Index (BIS) are not eligible for enrollment).
• Either male or female, aged ≥ 18 and ≤ 65 years old.
• Classified as grade I - III by the American Society of Anesthesiologists (ASA).
• Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m².
• Vital signs during the screening period meet the following criteria:
• Respiratory rate ≥ 10 and ≤ 24 breaths per minute. Pulse oxygen saturation (SpO2) ≥ 95% when breathing air. Systolic blood pressure (SBP) ≥ 90 mmHg and ≤ 160 mmHg. Diastolic blood pressure (DBP) ≥ 60 mmHg and ≤ 100 mmHg. Heart rate ≥ 55 and ≤ 100 beats per minute. (Note: The heart rate result of the 12-lead electrocardiogram (12-ECG) examination after signing the Informed Consent Form (ICF) shall be used as the basis for judgment.)
• ● Able to understand the procedures and methods of this study, willing to sign the informed consent form and strictly comply with the trial protocol to complete this study.

You may not qualify if:

• Those with contraindications for general anesthesia or a history of previous anesthesia accidents.
• Those known to be allergic to the excipients of cipepofol injection (soybean oil, glycerol, triglycerides, egg yolk lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, sugammadex sodium and their drug components; those with cross-allergy to halogenated anesthetics, and those who had jaundice and unexplained high fever after using halogenated agents before are prohibited; those with contraindications for propofol.
• Having the following medical history or evidence that increases the risk of sedation/anesthesia collected before or during the screening:
• Cardiovascular history: uncontrolled hypertension or systolic blood pressure (SBP) \> 160 mmHg and/or diastolic blood pressure (DBP) \> 100 mmHg after treatment with antihypertensive drugs, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina pectoris, myocardial infarction occurred within the recent 6 months before screening, a history of tachycardia/bradycardia requiring drug treatment, third-degree atrioventricular block.
• Respiratory history: respiratory insufficiency, a history of obstructive pulmonary disease, a history of bronchospasm requiring treatment within 3 months before screening, those who suffered from acute respiratory tract infection within 1 week before the baseline period and had one of the symptoms such as obvious fever, wheezing or expectorant cough.
• Neurological and psychiatric history: a history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; or a history of schizophrenia, mania, long-term use of psychotropic drugs, cognitive dysfunction, etc.
• Gastrointestinal history: a history of gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction, etc., and the investigator judges that it may lead to reflux aspiration.
• Diabetic patients with unsatisfactory blood glucose control (fasting blood glucose ≥ 11.1 mmol/L or random blood glucose ≥ 13.6 mmol/L).
• Having a history of diseases in the liver, kidney, blood system, nervous system or metabolic system that are not controlled and are judged by the investigator as not suitable for participating in this study and have significant clinical significance.
• A history of alcohol abuse within 3 months before screening.
• A history of drug abuse within 3 months before screening.
• Those who had severe infection, severe trauma or major surgical operations within 4 weeks before screening.
• Having any of the following risks in airway management before or during the screening:
• A history of asthma, wheezing.
• Those with sleep apnea syndrome.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

NOT YET RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Interventions

HSK3486

Study Officials

• Gao Jingui, Doctor

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao Jingui, Doctor

CONTACT

15803210586; gaojingui@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 6, 2025
• Primary Completion: March 30, 2025
• Study Completion: May 30, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)