The Neuroprotection Effect of Dexmedetomidine

Study Overview
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Brief Summary
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The brain protection effect of dexmedetomidine has been approved in several studies. Basically, the anti-inflammatory effects and reducing catecholamines are thought to be a main role of the protection effect. In many studies reported the advantage of dexmedetomidine as a substitution of other sedative drugs for anesthesia. The anesthesia of intra-cranial aneurysmal clipping operation commonly use intravenous anesthetic agents combined with inhalation anesthesia for neuroprotection, and mostly propofol is used. The aim of this study is to examine the effects of dexmedetomidine on serum inflammatory markers and research the hemodynamic stability of dexmedetomidine compared to propofol in aneurysmal clipping operation.

Official Title
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The Anti-inflammatory Effect and Hemodynamic Stability of Dexmedetomidine in Aneurysmal Clipping Operation; Compare With Propofol

Conditions
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Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I,II patient needs operation of intracranial aneurysmal clipping without SAH Exclusion Criteria: Any history of neurologic disease, dementia Allergic history of propofol or dexmedetomidine

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: propofol<br> | Drug: Propofol<br>* Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period<br>|
| Active Comparator: dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of inflammatory markers | CRP (mg/ml) | Baseline: Before injection study drugs | 
| The concentration of inflammatory markers | CRP (mg/ml) | 1 minute after operation | 
| The concentration of inflammatory markers | CRP (mg/ml) | Day 1 after operation | 
| The concentration of inflammatory markers | CRP (mg/ml) | Day 2 after operation | 
| The concentration of norepinephrine | NE (nmol/l) | Baseline: Before injection study drugs | 
| The concentration of norepinephrine | NE (nmol/l) | 1 minute after operation | 
| The concentration of norepinephrine | NE (nmol/l) | Day 1 after operation | 
| The concentration of norepinephrine | NE (nmol/l) | Day 2 after operation | 
| The concentration of inflammatory markers | IL-6, IL-8, IL-10 ,TNF-a (pg/ml) | Baseline: Before injection study drugs | 
| The concentration of inflammatory markers | IL-6, IL-8, IL-10 ,TNF-a (pg/ml) | 1 minute after operation | 
| The concentration of inflammatory markers | IL-6, IL-8, IL-10 ,TNF-a (pg/ml) | Day 1 after operation | 
| The concentration of inflammatory markers | IL-6, IL-8, IL-10 ,TNF-a (pg/ml) | Day 2 after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of hypotension or hypertension |  | during operation |