The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

Not Applicable

Completed

• Conditions: Brain Tumor; Cerebrovascular Disorders
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02878707
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-21
• Study First Posted: 2016-08-25
• Study Start: 2017-04-24
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Last Update Submitted: 2020-09-20
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
• age between 20 to 80 yr

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEX	Dexmedetomidine	Intraoperative intravenous infusion of dexmedetomidine
Control	Dexmedetomidine	Intraoperative intravenous infusion of 0.9% saline

Primary Outcome Measures

Name	Time	Method
Number of participants with postoperative neurological complications	during postoperative period of hospital admission, approximately 10 days by estimation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan