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Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly. |
|
| Control group | Placebo Comparator | Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| urapidil consumption | urapidil consumption was recorded by nurses every hour | the end of the 6th hour after tracheal extubation |
| Measure | Description | Time Frame |
|---|---|---|
| urapidil consumption on POD1 | urapidil consumption was recorded by nurses every hour | the total consumption of urapidil on post-operative day 1. |
| urapidil consumption on POD2 | urapidil consumption was recorded by nurses every hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Jiang, PhD | Contact | 86 20 28823350 | NJiang_sysu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Sun Yetsen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
the IPD will not be shared with others, since following investigations based on this trial is about to start.
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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two parallel groups
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this investigation is a triple mask study. The patiens, the care providers and Outcome Assessor will not allowed to know the grouping information.
| normal saline | Other | equal volume of normal saline was administered intravenously constantly after tracheal extubation. |
|
|
| the total consumption of urapidil on post-operative day 2. |
| Visual Analogue score | visual analogue score was measured by visual analogue scale | the end of the 6th hour after tracheal extubation |
| Visual Analogue score at 24th hour | visual analogue score was measured by visual analogue scale | the end of the 24th hour after tracheal extubation |
| Visual Analogue score at 48th hour | visual analogue score was measured by visual analogue scale | the end of the 48th hour after tracheal extubation |
| Quality of Recovery Score | Quality of Recovery Score was measured by a 15-item quality of recovery scale | the end of the 6th hour after tracheal extubation |
| Quality of Recovery Score at 24th hour | Quality of Recovery Score was measured by a 15-item quality of recovery scale | the end of the 24th hour after tracheal extubation |
| Quality of Recovery Score at 48th hour | Quality of Recovery Score was measured by a 15-item quality of recovery scale | the end of the 48th hour after tracheal extubation |
| Analgesics consumption | Analgesics consumption was recorded by nurse every hour | the end of the 6th hour after tracheal extubation |
| Analgesics consumption on POD1 | Analgesics consumption was recorded by nurse every hour | the total consumption of urapidil on post-operative day 1. |
| Analgesics consumption on POD2 | Analgesics consumption was recorded by nurse every hour | the total consumption of urapidil on post-operative day 2. |
| Bradycardia | a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse | the end of the 6th hour after tracheal extubation |
| Bradycardia at 24th hour | a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse | the end of the 24th hour after tracheal extubation |
| Bradycardia at 48th hour | a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse | the end of the 48th hour after tracheal extubation |
| PONV | post-operative nausea and vomiting (PONV) was recorded by nurse | the end of the 6th hour after tracheal extubation |
| PONV at 24th hour | post-operative nausea and vomiting (PONV) was recorded by nurse | the end of the 24th hour after tracheal extubation |
| PONV at 48th hour | post-operative nausea and vomiting (PONV) was recorded by nurse | the end of the 48th hour after tracheal extubation |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |