The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

National Taiwan University

Status: Completed

Conditions: Brain Tumor; Cerebrovascular Disorders

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02878707

201605056MIFA

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups, including a placebo group

DEX

Experimental group

Description:

Intraoperative intravenous infusion of dexmedetomidine

Treatment:

Drug: Dexmedetomidine

Control

Placebo Comparator group

Description:

Intraoperative intravenous infusion of 0.9% saline

Treatment:

Drug: Dexmedetomidine