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CompletedNCT02878707Updated Sep 22, 2020

The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

An interventional study of Dexmedetomidine in Brain Tumor and Cerebrovascular Disorders, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-22.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Brain Tumor
  • Cerebrovascular Disorders
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In context

Cerebrovascular Disorders

374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's enrollment of 160 is above the median of 110 across 214 interventional studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    DEX

    Intraoperative intravenous infusion of dexmedetomidine

    Drug: Dexmedetomidine

  • Placebo comparator
    Control

    Intraoperative intravenous infusion of 0.9% saline

    Drug: Dexmedetomidine

Interventions

  • DrugDexmedetomidine

    Intraoperative dexmedetomidine infusion

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What researchers measure

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

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

    Time frame: Between preoperative baseline and postoperative day one.

  3. Intraoperative haemodynamic profile

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

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Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
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References and documents

Publications

  • Chen PH, Tsuang FY, Lee CT, Yeh YC, Cheng HL, Lee TS, Chang YW, Cheng YJ, Wu CY. Neuroprotective effects of intraoperative dexmedetomidine versus saline infusion combined with goal-directed haemodynamic therapy for patients undergoing cranial surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Dec 1;38(12):1262-1271. doi: 10.1097/EJA.0000000000001532. PubMed 34101714 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02878707
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 25, 2016
Start date
Apr 24, 2017
Primary completion
Apr 14, 2020
Completion
Apr 14, 2020
Last update
Sep 22, 2020

Study contacts

Chun-Yu Wu, MD
principal investigator · Anesthesiology Department, National Taiwan University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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