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

NCT05971121 | Unknown

• 1 other identifier: NFEC-2022-525
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Ciprofol; Propofol; Sedation; Low Blood Pressure; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• The proportion of patients meeting the RASS sedation

  Professionally trained researchers perform RASS scores on patients at specific time points

  within 24 hours

Secondary Outcomes (6)

• Dosage of propofol or ciprofol during sedation (total dose/time of use)

  up to 24 hours

• Dosage of norepinephrine during sedation (total dose/time of use)

  up to 24 hours

• Duration of mechanical ventilation

  From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days

• Incidence of adverse events

  up to 3 days

• length of ICU stay

  up to 28 days

Study Arms (2)

ciprofol group

Hypotensive ICU patient sedated with ciprofol

Drug: ciprofol

propofol group

Hypotensive ICU patient sedated with propofol

Interventions

ciprofol DRUG

Ciprofol were used for sedation in ICU hypotensive patients

ciprofol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern medical university Nanfang hospital

Guangzhou, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Hypotension

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zengzhu He, master

CONTACT

+8615766358044; hzengzhu@163.com

Hongbin Hu, doctor

CONTACT

+8613922483752; hobewoos@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 2, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

CN (1)