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Completed

NCT Number: NCT06261996

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

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.

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Key information

Conditions

Invasive Mechanical Ventilation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital

Zhengzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fospropofol

Drug

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

Other names: fospropofol disodium

Primary outcomes

  1. The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions

    Time frame: Admission to the intensive care unit to 2 hours after weaning off the ventilator.

    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.

Secondary outcomes

  1. Incidence of adverse reactions during the follow-up period

    Time frame: 2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.

    Adverse effects include hypotension, bradycardia, tachycardia, agitation, pain at the injection site, nausea and vomiting, edema, fever, anemia, paresthesias, headache, and hypoxemia.

  2. Extubation time

    Time frame: From admission to the intensive care unit to removal of the endotracheal tube

    The time from admission to the intensive care unit to removal of the endotracheal tube

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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