Back to resultsThe Neuroprotective Effects of Dexmedetomidine During Brain Surgery
Primary Purpose
Brain Tumor, Cerebrovascular Disorders
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DEX
Control
Arm Description
Intraoperative intravenous infusion of dexmedetomidine
Intraoperative intravenous infusion of 0.9% saline
Outcomes
Primary Outcome Measures
Number of participants with postoperative neurological complications
Secondary Outcome Measures
Number of participants with postoperative delirium
Serum biomarkers changes
biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP
Intraoperative haemodynamic profile
Full Information
NCT ID
NCT02878707
First Posted
August 15, 2016
Last Updated
September 20, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02878707
Brief Title
The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
Official Title
The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
April 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Cerebrovascular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DEX
Arm Type
Experimental
Arm Description
Intraoperative intravenous infusion of dexmedetomidine
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Intraoperative intravenous infusion of 0.9% saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Intraoperative dexmedetomidine infusion
Primary Outcome Measure Information:
Title
Number of participants with postoperative neurological complications
Time Frame
during postoperative period of hospital admission, approximately 10 days by estimation
Secondary Outcome Measure Information:
Title
Number of participants with postoperative delirium
Time Frame
during postoperative period of hospital admission, approximately 10 days by estimation
Title
Serum biomarkers changes
Description
biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP
Time Frame
Between preoperative baseline and postoperative day one.
Title
Intraoperative haemodynamic profile
Time Frame
during intraoperative perioid, approximately 4-6 hours by estimation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, MD
Organizational Affiliation
Anesthesiology Department, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34101714
Citation
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.
Results Reference
derived
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The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
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