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Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil,midazolam | Experimental | Remifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation |
|
| Fentanyl,midazolam | Experimental | Fentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation |
|
| Normal saline | Placebo Comparator | Normal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug |
| ||
| Remifentanil |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and duration of delirium in patients with different regimens | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days | |
| Ventilator-free days | an expected average of 7 days | |
| Mean days of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Liu, Resident physician | Contact | +8613811365572 | fancyjuice@126.com |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077208 | Remifentanil |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
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|
| Normal saline | Drug |
|
| an expected average of 7 days |
| Length of ICU stay | an expected average of 7 days |
| Index of anesthesia depth monitoring | Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume | From admission to ICU to weaning,about 7 days |
| Infusion velocity and total dose of sedative drugs in different groups | From admission to ICU to extubation or drug withdrawal,about 7 days |
| Plasma melatonin level | Every 6 hours during the next ICU day |
| Total rescue dose of midazolam | Seven days after giving midazolam to patient |
| Variations of HR、RR、BP、SpO2 | an expected average of 7 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |