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Completed

NCT Number: NCT02878707

The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Intraoperative dexmedetomidine infusion

Primary outcomes

  1. Number of participants with postoperative neurological complications

    Time frame: during postoperative period of hospital admission, approximately 10 days by estimation

Secondary outcomes

  1. Number of participants with postoperative delirium

    Time frame: during postoperative period of hospital admission, approximately 10 days by estimation

  2. Serum biomarkers changes

    Time frame: Between preoperative baseline and postoperative day one.

    biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP

  3. Intraoperative haemodynamic profile

    Time frame: during intraoperative perioid, approximately 4-6 hours by estimation

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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