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

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.

Study Overview

• Status: Recruiting
• Conditions: Sedation; Propofol; Low Blood Pressure; Norepinephrine; Ciprofol
• Intervention / Treatment: Drug: ciprofol

• Study Type: Observational
• Enrollment (Estimated): 456

Contacts and Locations

• Study Contact: Name: Hongbin Hu, doctor; Phone Number: +8613922483752; Email: hobewoos@163.com
• Study Contact Backup: Name: Zengzhu He, master; Phone Number: +8615766358044; Email: hzengzhu@163.com

Study Locations

• China
  • Guangzhou, China, 510515
    • Recruiting
    • Southern Medical University Nanfang Hospital
    • Contact: Hongbin Hu, doctor; Phone Number: +8613922483752; Email: hobewoos@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ciprofol group; Hypotensive ICU patient sedated with ciprofol	Drug: ciprofol; Ciprofol were used for sedation in ICU hypotensive patients
propofol group; Hypotensive ICU patient sedated with propofol

What is the study measuring?

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
The mortality rate	Researchers obtain it through the hospital electronic system.	up to 28 days
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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: NFEC-2022-525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No