AnesthesiaseccsaNCT05892471
Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
A study testing ciprofol injection and Propofol injection in people with Anesthesia, run by Le Yu at 1 site in China.
Trial summary
Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- ciprofol injection and Propofol injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Sep 2023
- Phase
- Interventional
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery patients
- Aged 55 to 75
- New York Heart Association class II or III cardiac functions
- Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.
Who cannot join
- With a history of benzodiazepine allergy
- Significant liver or kidney insufficiency
- Coagulation dysfunction
- Neurological or psychiatric disorders
- Undergone major surgery within the past three months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital of Tongji University
Shanghai, Shanghai Municipality, 200120
Le Yu, MM, 19921875120, 907084943@qq.com
About this study
Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia
- Conditions
- Anesthesia
- Being tested
- ciprofol injection, Propofol injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofol injectionDrug
Also called Experimental
Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia
Propofol injectionDrug
Also called Placebo Comparator
Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| ciprofol | Experimental | Not described Receives: Drug: ciprofol injection |
| propofol | Placebo comparator | Not described Receives: Drug: Propofol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: 1 second before induction of anesthesia (T1)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: 1 second before tracheal intubation (T2)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: 1 minute after tracheal intubation (T3)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: 5 minutes after tracheal intubation (T4)
Heart beats
the number of times each minute that heart beats
Measured: 1 second before induction of anesthesia (T1)
Heart beats
the number of times each minute that heart beats
Measured: 1 second before tracheal intubation (T2)
Heart beats
the number of times each minute that heart beats
Measured: 1 minute after tracheal intubation (T3)
Heart beats
the number of times each minute that heart beats
Measured: 5 minutes after tracheal intubation (T4).
Secondary outcomes (3)
Oxygenation index
a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body.
Measured: 1 second before induction of anesthesia (T1)
Oxygenation index
a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body.
Measured: 10 minutes after tracheal intubation (T5).
Injection pain
Pain at the injection site when injecting the drug（Evaluation with Visual Analogue Scale）
Measured: During procedure (When injecting the drug, ask the subject if the injection site is painful)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (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.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Le Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Le Yu, Shanghai East Hospital of Tongji University
- Investigators
- Handong Sun, Study director, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892471
- Sponsor's protocol ID
- 2022.8.1-2023.8.1
- Acronym
- seccsa
- Status last verified
- Jun 2023
- First submitted
- 17 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
- ClinicalTrials.gov ID
- NCT05892471
- Acronym / sponsor ID
- seccsa / 2022.8.1-2023.8.1
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Le YuUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 7 Jun 2023 (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.
Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciprofol | Experimental | Drug: ciprofol injection |
| propofol | Placebo comparator | Drug: Propofol injection |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgery patients
- Aged 55 to 75
- New York Heart Association class II or III cardiac functions
- Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.
Key exclusion criteria (5 listed)
- With a history of benzodiazepine allergy
- Significant liver or kidney insufficiency
- Coagulation dysfunction
- Neurological or psychiatric disorders
- Undergone major surgery within the past three months.
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 |
|---|---|---|
| ciprofol injectionAlso: ExperimentalPatients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia | Drug | ciprofol |
| Propofol injectionAlso: Placebo ComparatorPatients in propofol group received 1.5 mg/kg propofol for induction of anesthesia | Drug | propofol |
Primary outcome
Mean arterial pressure
Time frame: 1 second before induction of anesthesia (T1)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
Time frame: 1 second before tracheal intubation (T2)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
Time frame: 1 minute after tracheal intubation (T3)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
Time frame: 5 minutes after tracheal intubation (T4)
an average blood pressure in an individual during a single cardiac cycle
Heart beats
Time frame: 1 second before induction of anesthesia (T1)
the number of times each minute that heart beats
Heart beats
Time frame: 1 second before tracheal intubation (T2)
the number of times each minute that heart beats
Heart beats
Time frame: 1 minute after tracheal intubation (T3)
the number of times each minute that heart beats
Heart beats
Time frame: 5 minutes after tracheal intubation (T4).
the number of times each minute that heart beats
3 secondary outcomes
Oxygenation index
Time frame: 1 second before induction of anesthesia (T1)
Oxygenation index
Time frame: 10 minutes after tracheal intubation (T5).
Injection pain
Time frame: During procedure (When injecting the drug, ask the subject if the injection site is painful)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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.
Handong Sun study director
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofol injection and Propofol injection in people with Anesthesia, run by Le Yu 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 4 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 7 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 LE YU (19921875120, 907084943@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: 1 second before induction of anesthesia (T1)). The study lists 8 primary outcomes in all. 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 7 Jun 2023.