AnesthesiaPhase 4NCT06740201
A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
A Phase 4 study testing Cipepofol in people with Anesthesia, run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Cipepofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 6 Jan 2025to 30 May 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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; subjects (including male subjects) who have a pregnancy plan within 3 months after the trial.
- Subjects who are considered by the investigator to have any other factors that are not suitable for participating in this trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei
Li Jianling, Doctor, +86 185 0314 7716, lyjianling@163.com
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Gao Jingui, Doctor, +86 15803210586, gaojingui@126.com
About this study
Official title: A Clinical Validation Study to Evaluate the Accuracy of a Target Controlled Infusion Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
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.
Read the detailed description
Subjects who meet the enrollment criteria will be randomly assigned at a 1:1 ratio to two groups with different plasma target-controlled concentrations (Cp) during the induction period: the low-concentration group (Group L) with a concentration of 0.9 μg/ml and the high-concentration group (Group H) with a concentration of 1.2 μg/ml. An interim analysis will be conducted after approximately 5% of the subject data has been collected in each group, including but not limited to indicators such as the effect-site equilibrium rate constant (Ke0).
- Conditions
- Anesthesia
- Being tested
- Cipepofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CipepofolDrug
Also called HSK3486
Adjust plasma target-controlled concentration
| Study group | Role | What they receive |
|---|---|---|
| Cp=0.9μg/ml | Experimental | Plasma target-controlled concentration 0.9μg/ml Receives: Drug: Cipepofol |
| Cp=1.2μg/ml | Experimental | Plasma target-controlled concentration 1.2μg/ml Receives: Drug: Cipepofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start6 Jan 2025
- Primary completion30 Mar 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gao Jingui, Doctor, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740201
- Sponsor's protocol ID
- HSK3486-408
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ce and Cp parameters
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Validation Study to Evaluate the Accuracy of a Target Controlled Infusion Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
- ClinicalTrials.gov ID
- NCT06740201
- Acronym / sponsor ID
- HSK3486-408
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects who meet the enrollment criteria will be randomly assigned at a 1:1 ratio to two groups with different plasma target-controlled concentrations (Cp) during the induction period: the low-concentration group (Group L) with a concentration of 0.9 μg/ml and the high-concentration group (Group H) with a concentration of 1.2 μg/ml. An interim analysis will be conducted after approximately 5% of the subject data has been collected in each group, including but not limited to indicators such as the effect-site equilibrium rate constant (Ke0).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cp=0.9μg/ml | Experimental | Drug: CipepofolPlasma target-controlled concentration 0.9μg/ml |
| Cp=1.2μg/ml | Experimental | Drug: CipepofolPlasma target-controlled concentration 1.2μg/ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (27 listed)
- 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:
- Having any of the following risks in airway management before or during the screening:
- Having used any of the following drugs or treatments before anesthesia induction:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CipepofolAlso: HSK3486Adjust plasma target-controlled concentration | Drug | Cp=0.9μg/ml, Cp=1.2μg/ml |
Primary outcome
Optimize the parameters CeLoC/CeRoC and Ke0 of the target-controlled infusion model of cipepofol.
Time frame: 2 h
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No. Ce and Cp parameters
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gao Jingui, Doctor principal investigator
Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cipepofol in people with Anesthesia, run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gao Jingui, Doctor (15803210586, gaojingui@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimize the parameters CeLoC/CeRoC and Ke0 of the target-controlled infusion model of cipepofol. (time frame: 2 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.