AnesthesiaPhase 3NCT06391931
A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery
A Phase 3 study testing Cipepofol and Propofol in people with Anesthesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients undergoing elective surgery Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Cipepofol and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2024to 28 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥2 years old and < 18 years old, gender is not limited;
- Selective surgery requiring tracheal intubation, mechanical ventilation and general anesthesia, with an estimated anesthetic time of 30 to 120 minutes;
- Intravenous anesthesia is suitable for both induction and maintenance of general anesthesia;
- ASA grade I-II;
- Before any activities related to the trial, the child's guardian or his/her guardian should sign the informed consent.
Who cannot join
- The type of operation is emergency rescue operation or emergency rescue is required during the operation or blood transfusion may be required according to the researchers;
- Patients with contraindications to general anesthesia or who have a history of anesthesia accidents;
- Known or suspected allergy to excipients in propofol injection, Cipepofol injection excipients (soybean oil, glycerol, triglyceride, yolk lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, atropine, etc., and their active ingredients; Contraindications of propofol injection;
- Prior to screening/baseline, the following medical history or evidence of increased risk of sedation/anesthesia was collected and was determined by the investigator to be inappropriate: Cardiovascular system diseases: severe congenital heart disease (such as tetralogy of Fallot, etc.), severe arrhythmias (such as tachycardia/bradycardia requiring medical treatment, degree III atrioventricular block), severe heart failure, etc.; Respiratory diseases: respiratory insufficiency, history of bronchospasm/asthma requiring treatment within 1 month prior to screening, acute upper respiratory infection with obvious fever, wheezing, or phlegm-producing cough within 1 week prior to baseline; Craniocerebral diseases: history of craniocerebral injury, convulsion, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; Or a known history of mental disorders, such as seizures, schizophrenia, mania, long-term use of psychiatric drugs, cognitive dysfunction; Gastrointestinal diseases: gastrointestinal retention, active bleeding, may lead to reflux aspiration and other conditions; a history of uncontrolled, clinically significant disease of the liver, kidney, hematological, nervous, or metabolic system; Patients with severe infection, trauma or major surgical operation within 4 weeks prior to screening; A history or family history of malignant hyperthermia.
- There are any of the following respiratory management risks within 1 week before screening: Asthma attacks, wheezing; Patients with failed tracheal intubation experience; The investigators assessed the risk of difficulty with mask ventilation or intubation.
- Participants who have participated in any drug clinical trial within 1 month before screening;
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- Laboratory examination indicators in the screening period/baseline period meet the following standards and are confirmed by review: alanine aminotransferase and/or ASpartate aminotransferase ≥ 5.0× Upper limit of normal (ULN); Total bilirubin ≥3.0×ULN; serum creatinine ≥2.5×ULN.
- Women who are fertile (i.e. post-menarche) and do not wish to use contraception throughout the trial period;
- Paediatric population requiring special care or supervision by courts/social welfare institutions;
- Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients undergoing elective surgery
- Conditions
- Anesthesia
- Being tested
- Cipepofol, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CipepofolDrug
0.6±0.2 mg/kg induce + 0.8 mg/kg/h maintain
PropofolDrug
3.0 mg/kg induce + 5.0 mg/kg/h maintain
| Study group | Role | What they receive |
|---|---|---|
| Cipepofol group | Experimental | Not described Receives: Drug: Cipepofol |
| Propofol group | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of anesthesia
Success rate of anesthesia induction and anesthesia maintenance
Measured: 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 Apr 2024
- Primary completion6 Nov 2024
- Study completion28 Nov 2024
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391931
- Sponsor's protocol ID
- HSK3486-310
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT06391931
- Acronym / sponsor ID
- HSK3486-310
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 30 Apr 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.
A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients undergoing elective surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cipepofol group | Experimental | Drug: Cipepofol |
| Propofol group | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≥2 years old and < 18 years old, gender is not limited;
- Selective surgery requiring tracheal intubation, mechanical ventilation and general anesthesia, with an estimated anesthetic time of 30 to 120 minutes;
- Intravenous anesthesia is suitable for both induction and maintenance of general anesthesia;
- ASA grade I-II;
- Before any activities related to the trial, the child's guardian or his/her guardian should sign the informed consent.
Key exclusion criteria (10 listed)
- The type of operation is emergency rescue operation or emergency rescue is required during the operation or blood transfusion may be required according to the researchers;
- Patients with contraindications to general anesthesia or who have a history of anesthesia accidents;
- Known or suspected allergy to excipients in propofol injection, Cipepofol injection excipients (soybean oil, glycerol, triglyceride, yolk lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, atropine, etc., and their active ingredients; Contraindications of propofol injection;
- Prior to screening/baseline, the following medical history or evidence of increased risk of sedation/anesthesia was collected and was determined by the investigator to be inappropriate: Cardiovascular system diseases: severe congenital heart disease (such as tetralogy of Fallot, etc.), severe arrhythmias (such as tachycardia/bradycardia requiring medical treatment, degree III atrioventricular block), severe heart failure, etc.; Respiratory diseases: respiratory insufficiency, history of bronchospasm/asthma requiring treatment within 1 month prior to screening, acute upper respiratory infection with obvious fever, wheezing, or phlegm-producing cough within 1 week prior to baseline; Craniocerebral diseases: history of craniocerebral injury, convulsion, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; Or a known history of mental disorders, such as seizures, schizophrenia, mania, long-term use of psychiatric drugs, cognitive dysfunction; Gastrointestinal diseases: gastrointestinal retention, active bleeding, may lead to reflux aspiration and other conditions; a history of uncontrolled, clinically significant disease of the liver, kidney, hematological, nervous, or metabolic system; Patients with severe infection, trauma or major surgical operation within 4 weeks prior to screening; A history or family history of malignant hyperthermia.
- There are any of the following respiratory management risks within 1 week before screening: Asthma attacks, wheezing; Patients with failed tracheal intubation experience; The investigators assessed the risk of difficulty with mask ventilation or intubation.
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 |
|---|---|---|
| Cipepofol0.6±0.2 mg/kg induce + 0.8 mg/kg/h maintain | Drug | Cipepofol group |
| Propofol3.0 mg/kg induce + 5.0 mg/kg/h maintain | Drug | Propofol group |
Primary outcome
Success rate of anesthesia
Time frame: 24 hours after the end of surgery
Success rate of anesthesia induction and anesthesia maintenance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cipepofol and Propofol in people with Anesthesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of anesthesia (time frame: 24 hours after the end of surgery). 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 22 Jul 2025.