Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients.
This is a randomized, open-label, small sample study using fospropofol disodium and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol disodium are to be evaluated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fospropofol disodium for injection | Experimental | Fospropofol disodium continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia.The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. |
|
| propofol | Active Comparator | Propofol continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol disodium for injection | Drug | Fospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent reaching sedation goals | Proportion of RASS assessment time points for subjects meeting target sedation levels among all RASS assessment time points during study drug administration without rescue sedation. | Within 7 days of the study began |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive ventilator free time within 7 days | The time without invasive ventilation within 7 days of the study began | Within 7 days of the study began |
| Rate of successful extubation within 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C472965 | fospropofol |
| D007267 | Injections |
| D000077208 | Remifentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011422 | Propionates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Propofol | Drug | Propofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. |
|
|
The proportion of participants who experienced successful extubation within 7 days of the study began
| Within 7 days of the study began |
| Incidence of unexpected extubation | Incidence of all extubation not planned by the attending physician | Within 7 days of the study began |
| Proportion of delirium in the ICU | Delirium as a percentage of all evaluable mental patients in the ICU | During ICU stay |
| Non-ICU survival time within 28 days | The time of survival outside of ICU within 7 days of the study began | Within 28 days of the study began |
| Case fatality rate within 28 days | After follow-up, the fatality rates of all enrolled patients (including those still in ICU, transferred out and discharge) within 28 days of the study began | Within 28 days of the study began |
| Percentage of time spent that trial drug was discontinued due to adverse events | Percentage of time the trial drug was discontinued due to any adverse event suspected to be related to the trial drug | Within 7 days of the study began |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |