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

Recruiting

• Conditions: Sedation; Low Blood Pressure; Propofol; Ciprofol; Norepinephrine
• Interventions: Drug: ciprofol

• Registration Number: NCT05971121
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-05-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 456

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ciprofol group	ciprofol	Hypotensive ICU patient sedated with ciprofol

Primary Outcome Measures

Name	Time	Method
The proportion of patients meeting the RASS sedation	within 24 hours	Professionally trained researchers perform RASS scores on patients at specific time points

Secondary Outcome Measures

Name	Time	Method
Dosage of norepinephrine during sedation (total dose/time of use)	up to 24 hours	Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
Dosage of propofol or ciprofol during sedation (total dose/time of use)	up to 24 hours	Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication
Incidence of adverse events	up to 3 days	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
Duration of mechanical ventilation	From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days	Responsible researchers obtain information by viewing electronic medical records
length of ICU stay	up to 28 days	Researchers obtain it through the hospital electronic system
The mortality rate	up to 28 days	Researchers obtain it through the hospital electronic system.

Trial Locations

Locations (1)

Southern medical university Nanfang hospital; 🇨🇳 Guangzhou, China