Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.

NCT06261996 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-15

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:

* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.

Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.

Conditions

  • Invasive Mechanical Ventilation

Interventions

DRUG

Fospropofol

Fospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jiaqiang Q Zhang, M.D · Henan Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2025-01-15
Completion
2025-01-15

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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 NCT06261996 on ClinicalTrials.gov