Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately. Exclusion Criteria: abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two parallel groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly. | Drug: Dexmedetomidine<br>* 1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.<br>* Other names: DEX;|
| Placebo Comparator: Control group<br>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. | Other: normal saline<br>* equal volume of normal saline was administered intravenously constantly after tracheal extubation.<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urapidil consumption | urapidil consumption was recorded by nurses every hour | the end of the 6th hour after tracheal extubation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, brain arteriovenous malformation, embolization, post-operative hypertension