CiprofolNCT05971121
Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
An observational study of Ciprofol and Propofol, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study was a single-center, prospective, 2-year observational cohort study. The study subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge according to the condition of the subjects)… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ciprofol
- How many people
- 456 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the Department of Critical Care Medicine, Nanfang Hospital, Southern Medical University, patients needing vasopressor drugs to maintain blood pressure while requiring sedation
Who may be able to join
- Age ≥ 18;
- It needs to be treated with vasopressors to maintain mean arterial pressure ≥65 mmHg;
- Sedative medication required for comfort, safety, and to facilitate life support measures;
- Obtain the informed consent of the human subjects or their legal representatives.
Who cannot join
- Pregnant patient;
- Patients with proven acute severe intracranial or spinal neurological disease due to vascular, intracranial dilatation, or injury;
- History of allergy to cyclopofol, propofol, eggs, or soy products;
- History of long-term use of benzodiazepines or opioids;
- Sedative drugs other than propofol or cyclopofol were used at enrollment, or propofol and cyclopofol were used alternately within 24 hours;
- The researchers judged that they are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern medical university Nanfang hospital
Guangzhou, 510515
Hongbin Hu, doctor, +8613922483752, hobewoos@163.com
About this study
This study was a single-center, prospective, 2-year observational cohort study. The study subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge according to the condition of the subjects), they were divided into groups: ciprofol group and propofol group. A total of 456 subjects were planned to be enrolled, including 304 subjects in the cyclopofol group and 152 subjects in the propofol group. The data of this study were obtained by extracting the routine clinical diagnosis and treatment records of the enrolled subjects.
- Conditions
- Ciprofol, Propofol, Sedation, Low Blood Pressure, Norepinephrine
- Being tested
- ciprofol
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
Ciprofol were used for sedation in ICU hypotensive patients
| Study group | Role | What they receive |
|---|---|---|
| ciprofol group | Hypotensive ICU patient sedated with ciprofol Receives: Drug: ciprofol | |
| propofol group | Hypotensive ICU patient sedated with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients meeting the RASS sedation
Professionally trained researchers perform RASS scores on patients at specific time points
Measured: within 24 hours
Secondary outcomes (6)
Dosage of propofol or ciprofol during sedation (total dose/time of use)
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
Measured: up to 24 hours
Dosage of norepinephrine during sedation (total dose/time of use)
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
Measured: up to 24 hours
Duration of mechanical ventilation
Responsible researchers obtain information by viewing electronic medical records
Measured: From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days
Incidence of adverse events
The occurrence of adverse events during the hospital period will be recorded in the medical record by the clinician or nurse, and the researcher will obtain the occurrence of adverse events (event type, time, treatment, results, etc.) through the medical record
Measured: up to 3 days
length of ICU stay
Researchers obtain it through the hospital electronic system
Measured: up to 28 days
The mortality rate
Researchers obtain it through the hospital electronic system.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CiprofolStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971121
- Sponsor's protocol ID
- NFEC-2022-525
- Status last verified
- Jul 2023
- First submitted
- 24 May 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05971121
- Acronym / sponsor ID
- NFEC-2022-525
- Conditions
- Ciprofol, Propofol, Sedation, Low Blood Pressure, Norepinephrine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 2 Aug 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.
This study was a single-center, prospective, 2-year observational cohort study. The study subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge according to the condition of the subjects), they were divided into groups: ciprofol group and propofol group. A total of 456 subjects were planned to be enrolled, including 304 subjects in the cyclopofol group and 152 subjects in the propofol group. The data of this study were obtained by extracting the routine clinical diagnosis and treatment records of the enrolled subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciprofol group | – | Drug: ciprofolHypotensive ICU patient sedated with ciprofol |
| propofol group | – | –Hypotensive ICU patient sedated with propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the Department of Critical Care Medicine, Nanfang Hospital, Southern Medical University, patients needing vasopressor drugs to maintain blood pressure while requiring sedation
Key inclusion criteria (4 listed)
- Age ≥ 18;
- It needs to be treated with vasopressors to maintain mean arterial pressure ≥65 mmHg;
- Sedative medication required for comfort, safety, and to facilitate life support measures;
- Obtain the informed consent of the human subjects or their legal representatives.
Key exclusion criteria (6 listed)
- Pregnant patient;
- Patients with proven acute severe intracranial or spinal neurological disease due to vascular, intracranial dilatation, or injury;
- History of allergy to cyclopofol, propofol, eggs, or soy products;
- History of long-term use of benzodiazepines or opioids;
- Sedative drugs other than propofol or cyclopofol were used at enrollment, or propofol and cyclopofol were used alternately within 24 hours;
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 were used for sedation in ICU hypotensive patients | Drug | ciprofol group |
Primary outcome
The proportion of patients meeting the RASS sedation
Time frame: within 24 hours
Professionally trained researchers perform RASS scores on patients at specific time points
6 secondary outcomes
Dosage of propofol or ciprofol during sedation (total dose/time of use)
Time frame: up to 24 hours
Dosage of norepinephrine during sedation (total dose/time of use)
Time frame: up to 24 hours
Duration of mechanical ventilation
Time frame: From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days
Incidence of adverse events
Time frame: up to 3 days
length of ICU stay
Time frame: up to 28 days
The mortality rate
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ciprofol and Propofol, run by Nanfang Hospital, Southern Medical University 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 6 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 2 Aug 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. 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 Zengzhu He, master (+8615766358044, hzengzhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients meeting the RASS sedation (time frame: within 24 hours). 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 2 Aug 2023.