Brain TumorNCT02878707
The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
A study testing Dexmedetomidine in people with Brain Tumor and Cerebrovascular Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Brain Tumor, Cerebrovascular Disorders
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2017to 14 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
- age between 20 to 80 yr
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Brain Tumor, Cerebrovascular Disorders
- Being tested
- Dexmedetomidine
- Medical subject headings
- Brain Neoplasms, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intraoperative dexmedetomidine infusion
| Study group | Role | What they receive |
|---|---|---|
| DEX | Experimental | Intraoperative intravenous infusion of dexmedetomidine Receives: Drug: Dexmedetomidine |
| Control | Placebo comparator | Intraoperative intravenous infusion of 0.9% saline Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative neurological complications
Measured: during postoperative period of hospital admission, approximately 10 days by estimation
Secondary outcomes (3)
Number of participants with postoperative delirium
Measured: during postoperative period of hospital admission, approximately 10 days by estimation
Serum biomarkers changes
biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP
Measured: Between preoperative baseline and postoperative day one.
Intraoperative haemodynamic profile
Measured: during intraoperative perioid, approximately 4-6 hours by estimation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start24 Apr 2017
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, MD, Principal investigator, Anesthesiology Department, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878707
- Sponsor's protocol ID
- 201605056MIFA
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
- ClinicalTrials.gov ID
- NCT02878707
- Acronym / sponsor ID
- 201605056MIFA
- Conditions
- Brain Tumor, Cerebrovascular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX | Experimental | Drug: DexmedetomidineIntraoperative intravenous infusion of dexmedetomidine |
| Control | Placebo comparator | Drug: DexmedetomidineIntraoperative intravenous infusion of 0.9% saline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
- age between 20 to 80 yr
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineIntraoperative dexmedetomidine infusion | Drug | Control, DEX |
Primary outcome
Number of participants with postoperative neurological complications
Time frame: during postoperative period of hospital admission, approximately 10 days by estimation
3 secondary outcomes
Number of participants with postoperative delirium
Time frame: during postoperative period of hospital admission, approximately 10 days by estimation
Serum biomarkers changes
Time frame: Between preoperative baseline and postoperative day one.
Intraoperative haemodynamic profile
Time frame: during intraoperative perioid, approximately 4-6 hours by estimation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 34101714Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu, MD principal investigator
Anesthesiology Department, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Brain Tumor and Cerebrovascular Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative neurological complications (time frame: during postoperative period of hospital admission, approximately 10 days by estimation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.