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Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

NCT05491278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients.

Conditions

  • Critical Illness

Interventions

DRUG

Fospropofol disodium for injection

Fospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.

DRUG

Propofol

Propofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.

Sponsors & Collaborators

  • Xiaobo Yang, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2023-06-15
Completion
2023-09-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491278 on ClinicalTrials.gov