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

NCT ID: NCT05971121

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

456 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-10-01

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.

Detailed Description

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Conditions

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Ciprofol Propofol Sedation Low Blood Pressure Norepinephrine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ciprofol group

Hypotensive ICU patient sedated with ciprofol

ciprofol

Intervention Type DRUG

Ciprofol were used for sedation in ICU hypotensive patients

propofol group

Hypotensive ICU patient sedated with propofol

No interventions assigned to this group

Interventions

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ciprofol

Ciprofol were used for sedation in ICU hypotensive patients

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southern medical university Nanfang hospital

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zengzhu He, master

Role: CONTACT

+8615766358044

Hongbin Hu, doctor

Role: CONTACT

+8613922483752

Facility Contacts

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Hongbin Hu, doctor

Role: primary

+8613922483752

Other Identifiers

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NFEC-2022-525

Identifier Type: -

Identifier Source: org_study_id

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