Actively Recruiting
A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During 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
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
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
AI-Powered 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
CONTACT
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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