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Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study

Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05971121
Enrollment
456
Registered
2023-08-02
Start date
2022-10-01
Completion date
2024-10-01
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ciprofol, Low Blood Pressure, Norepinephrine, Propofol, Sedation

Brief 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), 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.

Interventions

DRUGciprofol

Ciprofol were used for sedation in ICU hypotensive patients

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients meeting the RASS sedationwithin 24 hoursProfessionally trained researchers perform RASS scores on patients at specific time points

Secondary

MeasureTime frameDescription
Dosage of norepinephrine during sedation (total dose/time of use)up to 24 hoursResponsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
Duration of mechanical ventilationFrom endotracheal intubation to withdrawal from mechanical ventilation,up to 28 daysResponsible researchers obtain information by viewing electronic medical records
Dosage of propofol or ciprofol during sedation (total dose/time of use)up to 24 hoursResponsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
length of ICU stayup to 28 daysResearchers obtain it through the hospital electronic system
The mortality rateup to 28 daysResearchers obtain it through the hospital electronic system.
Incidence of adverse eventsup to 3 daysThe 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

Countries

China

Contacts

Primary ContactZengzhu He, master
hzengzhu@163.com+8615766358044
Backup ContactHongbin Hu, doctor
hobewoos@163.com+8613922483752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026