AzTrials
AzTrials

Cognitive DysfunctionNCT03585452

Effects of Dexmedetomidine on Cognitive Outcome and Brain Injury Markers

A study testing Dexmedetomidine Infusion and Propofol based general anesthesia in people with Cognitive Dysfunction, run by Michał Kowalczyk at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Dexmedetomidine is a drug with sedative, anxiolytic, and analgesic properties. Benefits of its use covers good sedations without respiratory suppression, reduced circulating catecholamines due to decreased sympathetic transmission and nociceptive transmission blocking resulting in lower needs for postoperative pain… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cognitive Dysfunction
What is being tested?
Dexmedetomidine Infusion and Propofol based general anesthesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 sitePoland
Study dates
1 Aug 2018to 31 Mar 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • all adult patients qualified for elective coronary artery bypass grafts (CABG), (with CPB) with good ejection fraction - above 40%.

Who cannot join

  • diabetic patients, neurological diseases, any autoimmune diseases, any internal carotid or vertebral artery obstruction, myocardial infarction, ejection fraction < 40%.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Michał Kowalczyk

    Lublin, Lublin Voivodeship, 20-867

Other trials in Poland

About this study

Official title: Effects of Dexmedetomidine on Cognitive Outcome and Brain Injury Markers After General Anesthesia for Cardiac Surgery on Cardiopulmonary Bypass

Dexmedetomidine is a drug with sedative, anxiolytic, and analgesic properties. Benefits of its use covers good sedations without respiratory suppression, reduced circulating catecholamines due to decreased sympathetic transmission and nociceptive transmission blocking resulting in lower needs for postoperative pain management. All these features are beneficial for cardiac surgery patients. What is more, it was find as an anesthesia agent.

Recently some protective effects were find, like reduced postoperative delirium occurrence with cardiac surgery dexmedetomidine sedated patients. Other study revealed that patient receiving dexmedetomidine during cardiac surgery and in the first 24 h postoperatively showed significant reductions in in-hospital and 30-day mortality as well as postsurgical delirium.

Although dexmedetomidine appears to reduce postoperative delirium, its role in prevention of neurological injury has not been well studied. To fulfil this gap we designed the study to investigate effects of dexmedetomidine use during cardiac surgery (with cardiopulmonary bypass - CPB) and in the first hours postoperatively on biomarkers of brain injury and cognitive function.

Read the detailed description

All adult patients qualified for elective coronary artery bypass grafts (CABG), (with CPB), under general anesthesia with good ejection fraction - above 40% will be eligible for the study. Patients will be sampling by simple 1:1 sampling into 2 groups:

  1. Control group (group C): patients with typical anesthetic regimen.
  2. Dexmedetomidine group (group D): regimen will be the same with additional dexmedetomidine infusion.

In both groups typical monitoring will be applied: heart rate (HR), mean arterial pressure (MAP), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), pulse oximetry (SpO2), central vein pressure (CVP), hemodynamic monitoring with Swan-Ganz thermodilution pulmonary artery catheter, end tidal carbon dioxide (ET CO2), typical inhaust and exhaust gases analysis, eeg sensor - SedLine with patient state index (PSI), (Masimo technology) and regional cerebral oximetry (Masimo technology) with estimation of area under curve defined as time of the low brain oximetry value below 80% of initial value.

Blood for bio-markers analysis will be collected in the following points:

  1. initially, before anesthesia induction
  2. At the end of the procedure
  3. 24 hours after procedure
  4. 72 hours after procedure Biochemical measures will cover: biomarkers of brain injury: myelin basic protein (MBP) and matrix metalloproteinase 12 (MMP12).

Cognitive function will be assessed using Addenbrooke's Cognitive Examination - ACE-III, at three time points: initially, one day before surgery, at discharge time and 3 months after discharge.

Being tested
Dexmedetomidine Infusion, Propofol based general anesthesia
Keywords
dexmedetomidine, cardiac surgery, brain injury biomarkers, cognitive examination
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine InfusionDrug

    Also called Dexdor

    Patients with additional dexmedetomidine infusion

  • Propofol based general anesthesiaDrug

    Also called Control

    Patients with typical anaesthetic regimens

Study groups in NCT03585452
Study groupRoleWhat they receive
Group CActive comparatorPatients with typical anesthetic regimen: premedication: 2 mg estazolam p.o. and 10 mg morphine s.c. - 1 hour before procedure. Preoxygenation and induction of anaesthesia: remifentanyl 1 µg/kg, etomidate 0.3 mg/kg, pancuronium 0.1 mg/kg and intubation. Maintenance of the anesthesia: remifentanyl 0.2-0.5 µg/kg/min and propofol 2-4 mg/kg/min infusions. Ventilation with Air/O2. Additionally: nitroglycerine infusion or phenylephrine 0.05-0.1 mg boluses will be used for normotension maintenance at demanding doses. Subsequently typical CABG procedure with normothermic CPB will be performed. Weaning from CPB will be performed with inotropic support (dobutamine) and vasodilator (nitroglycerine) administration - with patients dependent doses. Routine recovery after surgery.
Receives: Drug: Propofol based general anesthesia
Group DExperimentalRegimen will be the same with additional dexmedetomidine infusion: with loading dose: 0.5 µg/kg/h through 1 hour and then dose will be reduced to 0.25 µg/kg/h and infusion will be continued during surgery and postoperative period to the total dose of 200 µg. Anesthetics and opioids doses will be adjusted under hemodynamic and eeg sensor - SedLine Masimo.
Receives: Drug: Dexmedetomidine Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive function

    Cognitive function assessment with Addenbrooke's Cognitive Examination - ACE-III

    Measured: at discharge - 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2018
  2. Study start1 Aug 2018
  3. Primary completion30 Dec 2018
  4. Study completion31 Mar 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients were randomly divided into two groups by simple 1:1 randomisation using opaque envelopes: the control group (group CON; patients with typical anaesthetic regimens) and the dexmedetomidine group (group DEX; those with additional dexmedetomidine infusion).
Masking
Single blind
Who is masked
Participant
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03585452
Sponsor's protocol ID
Cardiodex
Status last verified
Oct 2022
First submitted
1 Jul 2018
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to attach row data as supplemental data during publishing process.

Publications

  • McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.

    PubMed 24703207

  • Brandao PG, Lobo FR, Ramin SL, Sakr Y, Machado MN, Lobo SM. Dexmedetomidine as an Anesthetic Adjuvant in Cardiac Surgery: a Cohort Study. Braz J Cardiovasc Surg. 2016 May-Jun;31(3):213-218. doi: 10.5935/1678-9741.20160043.

    PubMed 27737403

  • Chen S, Hua F, Lu J, Jiang Y, Tang Y, Tao L, Zou B, Wu Q. Effect of dexmedetomidine on myocardial ischemia-reperfusion injury. Int J Clin Exp Med. 2015 Nov 15;8(11):21166-72. eCollection 2015.

    PubMed 26885050

  • Cheng H, Li Z, Young N, Boyd D, Atkins Z, Ji F, Liu H. The Effect of Dexmedetomidine on Outcomes of Cardiac Surgery in Elderly Patients. J Cardiothorac Vasc Anesth. 2016 Dec;30(6):1502-1508. doi: 10.1053/j.jvca.2016.02.026. Epub 2016 Mar 3.

    PubMed 27435836

  • Gong Z, Ma L, Zhong YL, Li J, Lv J, Xie YB. Myocardial protective effects of dexmedetomidine in patients undergoing cardiac surgery: A meta-analysis and systematic review. Exp Ther Med. 2017 May;13(5):2355-2361. doi: 10.3892/etm.2017.4227. Epub 2017 Mar 13.

    PubMed 28565849

  • Ji F, Li Z, Young N, Moore P, Liu H. Perioperative dexmedetomidine improves mortality in patients undergoing coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):267-73. doi: 10.1053/j.jvca.2013.06.022. Epub 2013 Oct 29.

    PubMed 24182835

  • Perez-Zoghbi JF, Zhu W, Grafe MR, Brambrink AM. Dexmedetomidine-mediated neuroprotection against sevoflurane-induced neurotoxicity extends to several brain regions in neonatal rats. Br J Anaesth. 2017 Sep 1;119(3):506-516. doi: 10.1093/bja/aex222.

    PubMed 28969317

  • Wang Y, Han R, Zuo Z. Dexmedetomidine-induced neuroprotection: is it translational? Transl Perioper Pain Med. 2016;1(4):15-19.

    PubMed 28217717

  • van Dijk D, Keizer AM, Diephuis JC, Durand C, Vos LJ, Hijman R. Neurocognitive dysfunction after coronary artery bypass surgery: a systematic review. J Thorac Cardiovasc Surg. 2000 Oct;120(4):632-9. doi: 10.1067/mtc.2000.108901.

    PubMed 11003741

  • Mioshi E, Dawson K, Mitchell J, Arnold R, Hodges JR. The Addenbrooke's Cognitive Examination Revised (ACE-R): a brief cognitive test battery for dementia screening. Int J Geriatr Psychiatry. 2006 Nov;21(11):1078-85. doi: 10.1002/gps.1610.

    PubMed 16977673

  • Ottens AK, Golden EC, Bustamante L, Hayes RL, Denslow ND, Wang KK. Proteolysis of multiple myelin basic protein isoforms after neurotrauma: characterization by mass spectrometry. J Neurochem. 2008 Mar;104(5):1404-14. doi: 10.1111/j.1471-4159.2007.05086.x. Epub 2007 Nov 22.

    PubMed 18036155

  • Chelluboina B, Warhekar A, Dillard M, Klopfenstein JD, Pinson DM, Wang DZ, Veeravalli KK. Post-transcriptional inactivation of matrix metalloproteinase-12 after focal cerebral ischemia attenuates brain damage. Sci Rep. 2015 May 8;5:9504. doi: 10.1038/srep09504.

    PubMed 25955565

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine Infusion and Propofol based general anesthesia in people with Cognitive Dysfunction, run by Michał Kowalczyk at 1 site in Poland.

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 1 inclusion and 1 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 26 Oct 2022. 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 Poland. 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. 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?

Cognitive function (time frame: at discharge - 7 days after surgery). 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 NCT03585452, which also lists 12 linked publications.

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 26 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in