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

Effect of Sedation on Heart Rate Variability Clinical Trial

Official title:

RANDOMİZED,DOUBLE-BLİND TRİAL OF EFFECT OF DEXMEDETOMİDİNE AND MİDAZOLAM SEDATİON ON HEART RATE VARİABİLİTY AFTER CORONARY ARTERY BYPASS GRAFT SURGERY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03601091
• Other study ID #: 2018/3/53
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Sedation on Heart Rate Variability

Intervention

Drug:
• Precedex 200 MCG in 2 ML Injection
Infusion therapy of the drug
• DORMICUM 5MG/5 ML
Infusion therapy of the drug

Locations

Country	Name	City	State
Turkey	Mustafa Emre Gurcu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Low and high frequency of heart rate regarding with aritmia incidence	24 hours