The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

Study Overview
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Brief Summary
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Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.

Official Title
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The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

Conditions
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Brain Tumor, Cerebrovascular Disorders

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery age between 20 to 80 yr Exclusion Criteria: Fever, elevated white blood cell or C-reactive protein Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class Impaired renal function, cGFR< 60 ml/min/1.73 m2 Cardiac dysfunction, such as heart failure > NYHA class II

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEX<br>Intraoperative intravenous infusion of dexmedetomidine | Drug: Dexmedetomidine<br>* Intraoperative dexmedetomidine infusion<br>|
| Placebo Comparator: Control<br>Intraoperative intravenous infusion of 0.9% saline | Drug: Dexmedetomidine<br>* Intraoperative dexmedetomidine infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative neurological complications |  | during postoperative period of hospital admission, approximately 10 days by estimation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative delirium |  | during postoperative period of hospital admission, approximately 10 days by estimation | 
| Serum biomarkers changes | biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP | Between preoperative baseline and postoperative day one. | 
| Intraoperative haemodynamic profile |  | during intraoperative perioid, approximately 4-6 hours by estimation |