Brain Tumor, Cerebrovascular Disorders
Conditions
Brief summary
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.
Interventions
DRUGDexmedetomidine
Intraoperative dexmedetomidine infusion
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with postoperative neurological complications | during postoperative period of hospital admission, approximately 10 days by estimation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative delirium | during postoperative period of hospital admission, approximately 10 days by estimation | — |
| Serum biomarkers changes | Between preoperative baseline and postoperative day one. | biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP |
| Intraoperative haemodynamic profile | during intraoperative perioid, approximately 4-6 hours by estimation | — |
Countries
Taiwan
Outcome results
None listed