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EFFECT OF DEXMEDETOMİDİNE AND MİDAZOLAM SEDATİON ON HEART RATE VARİABİLİTY AFTER CORONARY ARTERY BYPASS GRAFT SURGERY

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ClinicalTrials.gov Identifier: NCT03601091
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Brief Summary:
The parasympathetic tone reduction and sympathetic tone enhancement, which are components of the autonomic nervous system (ANS) activity, increase the likelihood of malignant arrhythmias leading to ventricular fibrillation. Malignant arrhythmias are associated with high mortality and morbidity after coronary artery bypass graft (CABG) surgeries. Heart rate variability (HRV) is a physiological indicator of the effects of ANS activity on heart rate and is associated with a prognostic value for cardiac mortality. Dexmedetomidine has been shown to improve myocardial perfusion, reduce arrhythmia incidence, reduce inflammatory response, and reduce mortality in patients with coronary artery disease. The aim of this study investigate the effects of dexmedetomidine electrophysiologically on cardiac autonomic system by using HRV analysis for the purpose of sedation in patients who were followed up in the intensive care unit after coronary artery bypass graft surgery

Condition or disease Intervention/treatment Phase
Effect of Sedation on Heart Rate Variability Drug: Precedex 200 MCG in 2 ML Injection Drug: DORMICUM 5MG/5 ML Phase 4

Detailed Description:
Malignant arrhythmias are associated with high mortality and morbidity after coronary artery bypass graft (CABG) operations. Heart rate variability (HRV) is a physiological indicator of the effects of activity on heart ANS rate and has prognostic value for cardiac mortality. Spectral analysis of HRV can provide an assessment of adrenergic and cholinergic system activities during anesthesia. With the "power spectral" analysis of HRV, important clinical information can be obtained about the effects of anesthesia on the autonomic nervous system and the central nervous system. Decrease in HRV has a prognostic value for cardiac-induced mortality. The disease, which is transferred to intensive care unit (ICU) after CABG, is sedated with different medicines until the time of extubation. One commonly used sedative drug is deksmedetomidine, an α2 receptor agonist. Alpha 2 (α2) receptor agonist drugs reduce myocardial oxygen consumption and heart rate with sympatholytic properties. Therefore, deksmedetomidine can be safely and effectively used in patients undergoing cardiac surgery without pro-tachyarrhythmic and / or negative inotropic effects.In this study, it was aimed to investigate electrophysiologic effects of cardiac autonomic system by using HRV analysis in dexmedetomine and midazolam patients who underwent elective CABG and were used for sedation in the postoperative period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMISED- DOUBLE BLINDED
Masking: Double (Participant, Investigator)
Masking Description: DOUBLE BLINDED
Primary Purpose: Treatment
Official Title: RANDOMİZED,DOUBLE-BLİND TRİAL OF EFFECT OF DEXMEDETOMİDİNE AND MİDAZOLAM SEDATİON ON HEART RATE VARİABİLİTY AFTER CORONARY ARTERY BYPASS GRAFT SURGERY
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PR
PRECEDEX 200 mcg 2 ml,0,3 mcg/kg/h, intravenous continue infusion, 4 hours.
Drug: Precedex 200 MCG in 2 ML Injection
Infusion therapy of the drug

Active Comparator: DO
DORMICUM 5MG/5 ML, 0,1 mg/kh/h, intravenous continue infusion for 4 hours
Drug: DORMICUM 5MG/5 ML
Infusion therapy of the drug




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 24 hours ]
    Low and high frequency of heart rate regarding with aritmia incidence



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with pre-operative normal sinus rhythm
  • Ejection fraction (EF)> 45% on echocardiography (echocardiography) examination
  • 25 and 65 years of age will be included.

Exclusion Criteria:

  • Atrial fibrillation , atrial flutter, supraventricular tachycardia , AV block, ventricular extrasystole
  • Cardiopulmonary bypass have been reported in patients with diabetes mellitus (DM),
  • Chronic obstructive pulmonary disease (COPD),
  • Previous cerebrovascular event will be excluded from the study.
  • Patients receiving high-dose inotropic drug support after surgery (inotropic score of> 10 in the first 24 hours) and
  • Patients re-operated for bleeding revision will be removed from the study.

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): NCT03601091


Locations
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Turkey
Mustafa EMRE Gurcu
Istanbul, Turkey, 34865
Sponsors and Collaborators
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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Responsible Party: mustafa emre gürcü, Medical Doctor, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03601091     History of Changes
Other Study ID Numbers: 2018/3/53
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital:
dexmedetomidine
coronary artery bypass graft
heart rate variability

Additional relevant MeSH terms:
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Dexmedetomidine
Midazolam
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
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents