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Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(>64 years) after using sevoflurane anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane & Dexmedetomidine | Experimental | inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Dexmedetomidine 0.2µg/kg/h. |
|
| Sevoflurane & Placebo | Active Comparator | inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Placebo(for Dexmedetomidine )0.05ml/kg/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | inhale Sevoflurane |
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of agitation | stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes. | the duration of PACU room stay,expect 30 minutes |
| evaluation of pain | stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes. | the duration of PACU room stay,expect 30 minutes |
| the amount of drugs | when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using | the duration of hospital stay,expect 5 weeks |
| number of agitation | when stay in the hospital, measure the number of agitation. | the duration of hospital stay,expect 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the mean arterial pressure | measure the mean arterial pressure at 6 time points including after pump injection of Dexmedetomidine or normal saline 10 minutes, 20 minutes,30 minutes,before pulling out the endotracheal tube,at the time of pulling out the endotracheal tube,and after pulling out the endotracheal tube 5 minutes | from the beginning of induction to skin closure, up to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meiyan Sun | Contact | 15353575016 | smyszdlz@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Recruiting | Xi’an | Shanxi | China |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Dexmedetomidine | Drug | intravenous pumping Dexmedetomidine 0.2µg/kg/h |
|
|
| Placebo(for Dexmedetomidine) | Drug | normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h |
|
|
| heart rate | measure the heart rate at 6 time points including after pump injection of Dexmedetomidine or normal saline 10 minutes, 20 minutes,30 minutes,before pulling out the endotracheal tube,at the time of pulling out the endotracheal tube,and after pulling out the endotracheal tube 5 minutes | from the beginning of induction to skin closure, up to 1 hour |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D011596 | Psychomotor Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |