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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ciprofol, Propofol, Sedation, Low Blood Pressure, Norepinephrine

Intervention / Treatment
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* Drug: ciprofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ciprofol group<br>Hypotensive ICU patient sedated with ciprofol | Drug: ciprofol<br>* Ciprofol were used for sedation in ICU hypotensive patients<br>|
| propofol group<br>Hypotensive ICU patient sedated with propofol | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients meeting the RASS sedation | Professionally trained researchers perform RASS scores on patients at specific time points | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | up to 24 hours | 
| Duration of mechanical ventilation | Responsible researchers obtain information by viewing electronic medical records | 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 | up to 3 days | 
| length of ICU stay | Researchers obtain it through the hospital electronic system | up to 28 days | 
| The mortality rate | Researchers obtain it through the hospital electronic system. | up to 28 days |