The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

Brain Tumor Clinical Trial

Official title:

The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878707
• Other study ID #: 201605056MIFA
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: April 14, 2020

Study information

• Verified date: August 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Tumor
• Cerebrovascular Disorders

Intervention

Drug:
• Dexmedetomidine
Intraoperative dexmedetomidine infusion

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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