Anesthesia, GeneralPhase 4NCT05035069
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
A Phase 4 study testing Ciprofol and Propofol in people with Anesthesia, General, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Ciprofol and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2021to 4 Feb 2022
- Phase
- Phase 4
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient scheduled for TAVR through femoral artery access
- 1h ≤ Expected duration of surgery ≤ 3h
- Planned for general anesthesia without intubation
- 18 ≤ BMI ≤ 30
- ASA category Ⅱ～Ⅳ
Who cannot join
- Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
- Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
- Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
- Hemoglobin (HB) < 10.0 g / dl (100 g / L)
- Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Min Yan, M.D., zryanmin@zju.edu.cn
About this study
Official title: A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
Read the detailed description
This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.
- Conditions
- Anesthesia, General
- Being tested
- Ciprofol, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Ciprofol infusion, starting with 0.8 ~ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 ~ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60.
PropofolDrug
Propofol infusion, starting with 4 ~ 5mg/kg/h until BIS value below 60 (including 60), and then 1 ~ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol | Experimental | Not described Receives: Drug: Ciprofol |
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
Measured: Day 1
Secondary outcomes (4)
Time from the start of drug infusion to the first BIS reduction to 60
Measured: Day 1
Time from the end of drug infusion to the recovery of BIS to 90
Measured: Day 1
Percentage of subjects received rescue treatment
Measured: Day 1
Incidence of hypotension
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start3 Sep 2021 (estimated)
- Primary completion3 Feb 2022 (estimated)
- Study completion4 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Yan, M.D., Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035069
- Sponsor's protocol ID
- HSK3486-IIT-02
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT05035069
- Acronym / sponsor ID
- HSK3486-IIT-02
- Conditions
- Anesthesia, General
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2021 (estimated)
- Primary completion
- 3 Feb 2022 (estimated)
- Study completion
- 4 Feb 2022 (estimated)
- First posted
- 5 Sep 2021 (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.
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
Detailed description
This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol | Experimental | Drug: Ciprofol |
| Propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient scheduled for TAVR through femoral artery access
- 1h ≤ Expected duration of surgery ≤ 3h
- Planned for general anesthesia without intubation
- 18 ≤ BMI ≤ 30
- ASA category Ⅱ～Ⅳ
Key exclusion criteria (5 listed)
- Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
- Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
- Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
- Hemoglobin (HB) < 10.0 g / dl (100 g / L)
- Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
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 |
|---|---|---|
| CiprofolCiprofol infusion, starting with 0.8 ~ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 ~ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60. | Drug | Ciprofol |
| PropofolPropofol infusion, starting with 4 ~ 5mg/kg/h until BIS value below 60 (including 60), and then 1 ~ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60. | Drug | Propofol |
Primary outcome
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
Time frame: Day 1
4 secondary outcomes
Time from the start of drug infusion to the first BIS reduction to 60
Time frame: Day 1
Time from the end of drug infusion to the recovery of BIS to 90
Time frame: Day 1
Percentage of subjects received rescue treatment
Time frame: Day 1
Incidence of hypotension
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- 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.
Min Yan, M.D. principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Propofol in people with Anesthesia, General, 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 5 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangqiong Li (+86 02867258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value) (time frame: Day 1). 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 5 Sep 2021.