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| Name | Class |
|---|---|
| Chinese Medical Association | NETWORK |
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For the patient who passed the screen of weaning from ventilation, the traditional sedation drug such as propofol and midazolam should be decreased or stopped, then it would induce the stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that problem, the sedation should be given again. but if renewed to sedation, it would cause prolonged sedation and ventilation duration.
So as to resolve above issues, after the patient passed the screen of weaning, sedation is changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study to compare the efficacy and safety of sequential sedation of propofol or midazolam and dexmedetomidine in mechanical ventilated ICU patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol/Dexmedetomidine | Experimental |
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| Midazolam/Dexmedetomidine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl 0.7-1μg/kg,prn pain assessment is done every 4 hours,maintain Behavioral Pain Scale(BPS) 0-2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation duration | The time of intubation and the time of weaning from mechanical ventilation are recorded. | From intubation to weaning from mechanical ventilation, up to 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Using the Mini-mental State Examination(MMSE) to examine the delirium. | From the beginning of sedation to discharge from ICU, up to 28 days. |
| Blood pressure | blood pressure is recorded. |
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Inclusion Criteria:
Exclusion Criteria:
8) Unstable mental status and metal illness 9) Sure or suspected abuse of narcotics and alcohol independence 10) Allergy to experimental drug and other contraindication 11) Advanced tumor patients 12) Neuromuscular blockade other than for intubation 13) Pregnancy or lactation 14) Patient that participate other trial at past 30 days -
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| Name | Affiliation | Role |
|---|---|---|
| Jun Li, Professor | Tianjin Third Central Hospital | Principal Investigator |
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| Sedation assessment | Procedure | Sedation assessment is done every 4 hours,maintain the Riker Sedation Agitation Score(SAS) 3-4. |
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| Screen of weaning | Procedure | 1. Screen of weaning is done at 8:00 every morning. 2 If the patient is successful to wean, stop the Dexmedetomidine sedation. 3. If failed to wean, the patient is ventilated again and try to wean after 24 hours, until it is successful to wean and stop sedation, |
|
| Propofol | Drug | Propofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained. |
|
| Midazolam | Drug | Midazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained. |
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| Dexmedetomidine | Drug | After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4,the maximum dose is 1 mg/kg/h maintained,and prepare for weaning. |
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| From the beginning to weaning of sedation, up to 7 days. |
| Cost of sedation drug | The cost of sedation drug is calculated. | From the admition to discharge from ICU,up to 28 days. |
| Cost of narcotics | Cost of narcotics is calculated. | From the admition to discharge from ICU,up to 28 days. |
| Cost of ICU stay | From the beginning to weaning of sedation, up to 7 days. |
| Heart rate | From the beginning to weaning of sedation, up to 7 days. |
| Respiration Rate | From the beginning to weaning of sedation, up to 7 days. |
| Pulse blood oxygen saturation | From the beginning to weaning of sedation, up to 7 days. |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D015742 | Propofol |
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |
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