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

Invasive Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261996
• Other study ID #: henanFSH
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: February 2024
• Source: Henan Provincial People's Hospital
• Contact: Jiaqiang Q Zhang, M.D
• Phone: 0371 65580728
• Email: hnmzxh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Invasive Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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