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Effects of Dexmedetomidine on Cognitive Outcome and Brain Injury Markers

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ClinicalTrials.gov Identifier: NCT03585452
Recruitment Status : Active, not recruiting
First Posted : July 13, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Michał Kowalczyk, Medical University of Lublin

Brief 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 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.


Condition or disease Intervention/treatment
Cognitive Dysfunction Drug: Dexmedetomidine Infusion

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.


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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effects of Dexmedetomidine on Cognitive Outcome and Brain Injury Markers After General Anesthesia for Cardiac Surgery on Cardiopulmonary Bypass
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group C
Patients 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.
Group D
Regimen 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.
Drug: Dexmedetomidine Infusion
Additional dexmedetomidine infusion, as an element of general anesthesia
Other Name: Dexdor




Primary Outcome Measures :
  1. Brain injury biomarkers [ Time Frame: 72 hours after surgery ]
    Myelin basic protein and matrix metalloproteinase 12


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: 3 months after hospital discharge ]
    Cognitive function assessment with Addenbrooke's Cognitive Examination - ACE-III


Biospecimen Retention:   Samples Without DNA
The venous blood samples were collected into 4.9 ml blood collection tubes (for clot). Cells were removed by centrifugation for 10 min at 2500xg. After centrifugation, serum samples were aliquoted and stored at -80º.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients qualified for elective coronary artery bypass grafts
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585452


Locations
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Poland
Michał Kowalczyk
Lublin, Lubelskie, Poland, 20-867
Sponsors and Collaborators
Michał Kowalczyk
Investigators
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Principal Investigator: Michał Kowalczyk, M.D., Ph.D. Medical University of Lublin, Poland

Publications:

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Responsible Party: Michał Kowalczyk, Principal Investigator, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03585452     History of Changes
Other Study ID Numbers: Cardiodex
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to attach row data as supplemental data during publishing process.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will become available after article publication.
Access Criteria: Available for everybody.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michał Kowalczyk, Medical University of Lublin:
dexmedetomidine
cardiac surgery
brain injury biomarkers
cognitive examination

Additional relevant MeSH terms:
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Brain Injuries
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action