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

Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation in Anesthesiology Intensive Care Unit: A Preliminary Study

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.

Study Overview

• Status: Completed
• Conditions: Invasive Mechanical Ventilation
• Intervention / Treatment: Drug: Fospropofol

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhengzhou, China
    • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-75 years old
2. Intubation and mechanical ventilation <12h before enrollment
3. Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU).
4. Signed informed consent

Exclusion Criteria:

1. parturient, childbirth or lactating mothers
2. acute severe neurological disease or coma
3. chronic renal failure
4. previous mechanical ventilation >12h
5. severe liver dysfunction (Child-Pugh score C)
6. BMI >30kg/m2 (>90kg)
7. dying

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fospropofol group; Fospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h.	Drug: Fospropofol; Fospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h.; Other Names: fospropofol disodium
Placebo Comparator: Propofol group; Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h.	Drug: Fospropofol; Fospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h.; Other Names: fospropofol disodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions	The participant's RASS score was assessed by the caregiver and the occurrence of adverse reactions was recorded. Adverse effects include hypotension, bradycardia, tachycardia, agitation, pain at the injection site, nausea and vomiting, edema, fever, anemia, paresthesias, headache, and hypoxemia.	Admission to the intensive care unit to 2 hours after weaning off the ventilator.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions during the follow-up period	Adverse effects include hypotension, bradycardia, tachycardia, agitation, pain at the injection site, nausea and vomiting, edema, fever, anemia, paresthesias, headache, and hypoxemia.	2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.
Extubation time	The time from admission to the intensive care unit to removal of the endotracheal tube	From admission to the intensive care unit to removal of the endotracheal tube

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Investigators: Study Chair: Jiaqiang Q Zhang, M.D, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Propofol; sedation; Invasive mechanical ventilation; Fospropofol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; fospropofol
• Other Study ID Numbers: henanFSH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No