ClinicalTrials.Veeva

Menu

The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

National Taiwan University logo

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems