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

Zhengzhou University

Status: Not yet enrolling

Conditions: Invasive Mechanical Ventilation

Treatments: Drug: Fospropofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06261996

henanFSH

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-65 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Fospropofol group

Active Comparator group

Description:

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

Treatment:

Drug: Fospropofol

Propofol group

Placebo Comparator group

Description:

Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h.

Treatment:

Drug: Fospropofol