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

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971121
• Other study ID #: NFEC-2022-525
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Zengzhu He, master
• Phone: +8615766358044
• Email: hzengzhu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Low Blood Pressure
• Propofol
• Sedation

Intervention

Drug:
• ciprofol
Ciprofol were used for sedation in ICU hypotensive patients

Locations

Country	Name	City	State
China	Southern medical university Nanfang hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients meeting the RASS sedation	Professionally trained researchers perform RASS scores on patients at specific time points	within 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	length of ICU stay	Researchers obtain it through the hospital electronic system	up to 28 days
Secondary	The mortality rate	Researchers obtain it through the hospital electronic system.	up to 28 days