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

Not Applicable

Not yet recruiting

• Conditions: Invasive Mechanical Ventilation
• Interventions: Drug: Fospropofol

• Registration Number: NCT06261996
• Lead Sponsor: Henan Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study Start: 2024-02-12
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fospropofol group	Fospropofol	Fospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h.
Propofol group	Fospropofol	Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h.

Primary Outcome Measures

Name	Time	Method
The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions	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 Outcome Measures

Name	Time	Method
Incidence of adverse reactions during the follow-up period	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.
Extubation time	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