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

N/AUnknownNCT06261996

Henan Provincial People's Hospital200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Invasive Mechanical Ventilation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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

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