Clinical trial NCT05971121: Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
Official title: Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ciprofol
Propofol
Sedation
Low Blood Pressure
Norepinephrine
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.


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.

Primary outcomes:
measure: The proportion of patients meeting the RASS sedation
timeFrame: within 24 hours
Secondary outcomes:
measure: Dosage of propofol or ciprofol during sedation (total dose/time of use)
timeFrame: up to 24 hours
measure: Dosage of norepinephrine during sedation (total dose/time of use)
timeFrame: up to 24 hours
measure: Duration of mechanical ventilation
timeFrame: From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days
measure: Incidence of adverse events
timeFrame: up to 3 days
measure: length of ICU stay
timeFrame: up to 28 days
measure: The mortality rate
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university Nanfang hospital
Study officials:
References: