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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:
Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fospropofol group | Active Comparator | Fospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h. |
|
| Propofol group | Placebo Comparator | Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol | Drug | Fospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiaqiang Q Zhang, M.D | Henan Provincial People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhengzhou | China |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
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| 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 |