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Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubationļ¼in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finallyļ¼the investigators will compare the sedation effect and safety between the 2 groups ļ¼to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental |
| |
| propofol group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | participants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine. |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of time in the target sedation range | The primary outcome was the percentage of time in the target sedation range without rescue sedation. | up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| extubation time | from stopping sedative medication to removing the endotracheal tube | up to 2 days |
| extubation success rate | no re-intubation within 48 hours after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wenqiao PhD | Contact | +86-18868787588 | yuwenqiao1980@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First afflilated hospital of zhejiang university school of medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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After the study results are published
You can explain the reason and contact the study initiator via email to request the data. The email address is:yuwenqiao1980@zju.edu.cn
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Propofol | Drug | participants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine. |
|
| up to 4 days |
| changes in blood pressure | dynamic changes of blood pressure were recorded during sedation | up to 2 days |
| changes in heart rate | dynamic changes of heart rate were recorded during sedation | up to 2 days |
| ventilator-free days | ventilator-free days at day 7 | From enrollment to 7 days |
| the score of confusion assessment method for the intensive care unit ( CAM-ICU) | diagnose the delirium by the CAM-ICU scoreļ¼and calculate the incidence of delirium | From enrollment to the end of treatment at 28 days |
| stay length | length of intensive care unit stay and hospital stay | From enrollment to the end of treatment at 28 days |
| 28-day mortality | 28-day mortality after enrollment | From enrollment to the end of treatment at 28 days |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |