Actively Recruiting
Clinical Validation of a Target Controlled Infusion Model of Cipepofol in General Anesthesia During Elective Surgery
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-01-27
40
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center, randomized, open-label clinical study to evaluate and improve the accuracy of the target-controlled infusion (TCI) model for cipepofol during general anesthesia in patients undergoing elective surgery. The study aims to verify and optimize the infusion parameters to ensure precise control of drug delivery in this setting. Participants will be randomly assigned to one of two groups receiving different plasma target-controlled concentrations of cipepofol during anesthesia induction: a low concentration group (0.9 bcg/ml) and a high concentration group (1.2 bcg/ml). An interim analysis will be done after collecting about 5% of data from each group to evaluate key parameters like the effect-site equilibrium rate constant (Ke0). During the study, participants will undergo general anesthesia with tracheal intubation for elective surgeries lasting at least one hour. Researchers will monitor vital signs, anesthesia effects, and infusion accuracy, focusing on optimizing parameters such as CeLoC/CeRoC and Ke0 within two hours. The study will include screening for eligibility, informed consent, and close observation throughout surgery with ongoing assessments to ensure safety and data quality.
CONDITIONS
Brief Title
A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inpatient patients scheduled for elective surgeries requiring tracheal intubation under general anesthesia, with expected surgery duration 2 1 hour, excluding emergency, cardiothoracic, or neurosurgery cases
- Male or female aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status grade I to III
- Body Mass Index (BMI) between 18 and 30 kg/m8
- Vital signs within specified ranges: respiratory rate 10-24 breaths per minute; oxygen saturation 2 95% on air; systolic blood pressure 90-160 mmHg; diastolic blood pressure 60-100 mmHg; heart rate 55-100 beats per minute
- Ability to understand study procedures, willingness to sign informed consent, and comply with trial protocol
You will not qualify if you...
- Contraindications for general anesthesia or history of anesthesia accidents
- Allergy to cipepofol injection components or related anesthetic drugs
- Medical history increasing sedation/anesthesia risk, including uncontrolled hypertension, severe arrhythmia, heart failure, recent myocardial infarction, severe respiratory diseases, neurological or psychiatric disorders, gastrointestinal issues, uncontrolled diabetes, or significant liver, kidney, blood, nervous system, or metabolic diseases
- Recent history of alcohol or drug abuse within 3 months
- Recent severe infection, trauma, or major surgery within 4 weeks
- Airway management risks such as asthma, sleep apnea, malignant hyperthermia history, failed intubation, or difficult airway assessment
- Use of certain drugs or participation in other drug trials within specified timeframes before anesthesia
- Laboratory abnormalities including low neutrophil, platelet counts, or hemoglobin levels
- Pregnant or lactating women, or individuals unwilling to use contraception during the trial period
- Any other factors judged by investigators as unsuitable for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 hour during surgery
Participants receive general anesthesia with cipepofol at one of two plasma target-controlled concentrations during elective surgery.
1 visit (in-person surgical procedure)
Duration - Approximately 2 hours
Participants are monitored after surgery to assess anesthesia effects and optimize infusion model parameters.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Not Yet Recruiting
2
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
G
Gao Jingui, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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