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To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and follow up for 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine,tramadol and flurbiprofen | Experimental | Both sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients. |
|
| Tramadol and flurbiprofen | Active Comparator | Only routine analgesic(tramadol and flurbiprofen) are applied to this group of patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine, tramadol and flurbiprofen | Drug |
| ||
| tramadol and flurbiprofen |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain assessed by Prince Henry Pain Scale | assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU | 1-3d after gastrectomy |
| recovery of gastrointestinal function assessed by time to first defecation after surgery | assessed by time to first defecation after surgery | 30 days after gastrectomy |
| white blood cell count (10^9/L) | evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy | 1-3d after gastrectomy |
| C-reactive protein (mg/L) | evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy | 1-3d after gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of time within target sedation range | assessed by Richmond Agitation-Sedation Scale by investigators at 8:00 am after surgeries until discharge from ICU, the target range is -2 to +1 | 1-3d after gastrectomy |
| risk of bradycardia requiring interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minhua Cheng, M.D. | Contact | 15951813384 | cmhnju@163.com | |
| Wenkui Yu, Ph.D. | Contact | 13701582986 | yudrnj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of General Surgery of Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210002 | China |
Main results and conclusion will be available
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| Drug |
|
heart rate <40/min is considered bradycardia |
| 1-3d after gastrectomy |
| risk of hypotension requiring interventions | systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension | 1-3d after gastrectomy |
| use of opioids and use of benzodiazepins | 1-3d after gastrectomy |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D014147 | Tramadol |
| D005480 | Flurbiprofen |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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