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

N

Nanfang Hospital, Southern Medical University

Status

Enrolling

Conditions

Low Blood Pressure
Propofol
Ciprofol
Norepinephrine
Sedation

Treatments

Drug: ciprofol

Study type

Observational

Funder types

Other

Identifiers

NCT05971121
NFEC-2022-525

Details and patient eligibility

About

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.

Enrollment

456 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

456 participants in 2 patient groups

ciprofol group
Description:
Hypotensive ICU patient sedated with ciprofol
Treatment:
Drug: ciprofol
propofol group
Description:
Hypotensive ICU patient sedated with propofol

Trial contacts and locations

1

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Central trial contact

Zengzhu He, master; Hongbin Hu, doctor

Data sourced from clinicaltrials.gov

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