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The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for deep sedation in mechanically ventilated ICU patients.
This is a randomized, open-label, small sample study using fospropofol disodium and propofol for deep 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 and propofol are to be monitoted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fospropofol disodium for injection | Experimental | Patients in the experimental group received fospropofol disodium for injection at an initial infusion rate of 10 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64. |
|
| Propofol | Active Comparator | Patients in the active comparator group received propofol at an initial infusion rate of 3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol disodium for injection | Drug | Patients in the experimental group received fospropofol disodium for injection at an initial infusion rate of 10 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of time in the target sedation range without rescue sedation | The percentage of time in the target sedation range without rescue sedation | From start of study to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence rate of adverse events | From start of study to 48 hours |
| 7-day ventilator free time | 7-day ventilator free time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaobo Yang | Contact | 13720311349 | want.tofly@aliyun.com | |
| You Shang | Contact | 15972127819 | you_shanghust@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40211146 | Derived | Gao X, Gao C, Fang X, Ren L, Zhang H, Tang Y, Yuan Y, Qi H, Shu H, Zou X, Yang X, Shang Y. Fospropofol disodium versus Propofol for deep sedation in critically ill patients: a randomized pilot study. BMC Anesthesiol. 2025 Apr 10;25(1):166. doi: 10.1186/s12871-025-03025-x. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
| D007267 | Injections |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D010636 | Phenols |
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| Propofol | Drug | Propofol |
|
| From start of study to 7 days |
| Success rate of extubation within 7 days | Success rate of extubation within 7 days | From start of study to 7 days |
| Length of ICU stay | Length of ICU stay | From start of study to 28 days |
| 28-day mortality | 28-day mortality | From start of study to 28 days |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |