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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-22

Study Completion Date

2021-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Effect of Sedation on Heart Rate Variability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RANDOMISED- DOUBLE BLINDED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

DOUBLE BLINDED

Study Groups

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PR

PRECEDEX 200 mcg 2 ml,0,3 mcg/kg/h, intravenous continue infusion, 4 hours.

Group Type ACTIVE_COMPARATOR

Precedex 200 MCG in 2 ML Injection

Intervention Type DRUG

Infusion therapy of the drug

DO

DORMICUM 5MG/5 ML, 0,1 mg/kh/h, intravenous continue infusion for 4 hours

Group Type ACTIVE_COMPARATOR

DORMICUM 5MG/5 ML

Intervention Type DRUG

Infusion therapy of the drug

Interventions

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Precedex 200 MCG in 2 ML Injection

Infusion therapy of the drug

Intervention Type DRUG

DORMICUM 5MG/5 ML

Infusion therapy of the drug

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes