Actively Recruiting
Study to Validate Accuracy of Target-Controlled Infusion Model of Cipepofol During General Anesthesia for Elective Surgery
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-01-27
40
Participants Needed
2
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center, randomized, open-label Phase 4 study to evaluate and improve the accuracy of a target-controlled infusion (TCI) model of cipepofol in patients undergoing general anesthesia for elective surgeries. The study focuses on patients aged 18 to 65 who require tracheal intubation and general anesthesia during surgeries expected to last at least one hour. The goal is to verify parameters of the infusion model to help optimize dosing during anesthesia. 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 at 0.9 micrograms per milliliter and a high concentration group at 1.2 micrograms per milliliter. An interim analysis will be performed after about 5% of data is collected to assess key pharmacokinetic parameters such as the effect-site equilibrium rate constant (Ke0). Treatment involves intravenous administration of cipepofol with carefully adjusted target concentrations. During the study, participants will be closely monitored with assessments including vital signs and laboratory tests to ensure safety and adherence to protocol. Researchers will optimize the infusion model parameters based on these measurements within a 2-hour observation period focused on the effect-site equilibrium. The study excludes patients with conditions or histories that increase anesthesia risks. Overall participation will last through the surgery and immediate postoperative monitoring to evaluate anesthesia control and safety.
CONDITIONS
Official 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 of at least 1 hour, excluding emergency, cardiothoracic, or neurosurgery departments
- Male or female between 18 and 65 years old
- Classified as ASA grade I to III
- Body Mass Index between 18 and 30 kg/m²
- Respiratory rate between 10 and 24 breaths per minute during screening
- Pulse oxygen saturation (SpO2) of 95% or higher when breathing air
- Systolic blood pressure between 90 and 160 mmHg and diastolic between 60 and 100 mmHg during screening
- Heart rate between 55 and 100 beats per minute based on ECG after informed consent
- Able to understand study procedures and willing to sign informed consent and comply with protocol
You will not qualify if you...
- Contraindications for general anesthesia or history of anesthesia accidents
- Known allergies to cipepofol excipients or related drugs including benzodiazepines, opioids, rocuronium bromide, sugammadex sodium, halogenated anesthetics, or propofol
- Medical history increasing sedation/anesthesia risk such as uncontrolled hypertension, severe arrhythmia, heart failure, recent myocardial infarction, severe respiratory diseases, neurological or psychiatric disorders, gastrointestinal issues increasing aspiration risk
- Poorly controlled diabetes with fasting blood glucose ≥ 11.1 mmol/L or random blood glucose ≥ 13.6 mmol/L
- Uncontrolled diseases of liver, kidney, blood, nervous, or metabolic systems judged unsuitable by investigator
- History of alcohol or drug abuse within 3 months before screening
- Recent severe infection, trauma, or major surgery within 4 weeks before screening
- Airway management risks including history of asthma, wheezing, sleep apnea, malignant hyperthermia, failed tracheal intubation, or difficult airway
- Participation in other drug trials within 1 month before screening
- Use of propofol, other sedatives, anesthetics, or opioids within 4 hours before anesthesia induction
- Abnormal lab values during screening such as low neutrophil count, low platelet count, or low hemoglobin without recent transfusion
- Pregnant or breastfeeding women; those unwilling to use contraception during the trial; planning pregnancy within 3 months after trial
- Other factors judged by investigator as unsuitable for participation
AI-Screening
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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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