Clinical trial

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

Name
NFEC-2022-525
Description
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.
Trial arms
Trial start
2022-10-01
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Recruiting
Treatment
ciprofol
Ciprofol were used for sedation in ICU hypotensive patients
Arms:
ciprofol group
Size
456
Primary endpoint
The proportion of patients meeting the RASS sedation
within 24 hours
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'enrollmentInfo': {'count': 456, 'type': 'ESTIMATED'}}
Updated at
2023-08-02

1 organization

1 product

5 indications

Product
ciprofol
Indication
Ciprofloxacin
Indication
Propofol
Indication
Sedation
Indication
Hypotension
Indication
Norepinephrine