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New treatment option for Anesthesia
Official title A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
ClinicalTrials.gov ID: NCT06740201
What this study is testing
What is Cipepofol?
Cipepofol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anesthesia.
Also referred to as HSK3486.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Inpatient patients scheduled for elective surgeries that require tracheal intubation under general anesthesia, with the expected duration of surgery...
- 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...
You likely can't join 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...
- 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...
- Respiratory history: respiratory insufficiency, a history of obstructive pulmonary disease, a history of bronchospasm requiring treatment within 3...
- Neurological and psychiatric history: a history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Those with a history or family history of malignant hyperthermia.
- Those with a history of failed tracheal intubation.
- The investigator judges that there is a difficult airway or it is determined as difficult tracheal intubation (modified Mallampati score is grade III or IV).
- Having used any of the following drugs or treatments before anesthesia induction:
- Those who participated in any drug clinical trials within 1 month before screening.
- Those who used propofol, other general sedative/anesthetic drugs and/or opioid analgesics or compound preparations containing opioid analgesic components within 4 hours before anesthesia induction.
- Laboratory examination indexes during the screening period meet the following standards and are confirmed by reexamination:
- Neutrophil count \< 1.5 × 10⁹/L.
- Platelet count \< 80 × 10⁹/L.
- Hemoglobin \< 90 g/L (and without blood transfusion within 14 days).
- Pregnant and lactating women; fertile women or men who are unwilling to use contraception during the entire trial period; people (including male people) who have a pregnancy plan within 3 months after the trial.
- people who are considered by the investigator to have any other factors that are not suitable for participating in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Chengde, Hebei, China
- Shijiazhuang, Hebei, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengde, Hebei, China; Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.