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

NCT03601091 | Unknown

• 1 other identifier: 2018/3/53
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Effect of Sedation on Heart Rate Variability

Keywords

dexmedetomidine; coronary artery bypass graft; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  Low and high frequency of heart rate regarding with aritmia incidence

  24 hours

Study Arms (2)

PR

ACTIVE COMPARATOR

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

Drug: Precedex 200 MCG in 2 ML Injection

DO

ACTIVE COMPARATOR

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

Drug: DORMICUM 5MG/5 ML

Interventions

Precedex 200 MCG in 2 ML Injection DRUG

Infusion therapy of the drug

PR

DORMICUM 5MG/5 ML DRUG

Infusion therapy of the drug

DO

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Mustafa Emre Gurcu

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine; Injections; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: DOUBLE BLINDED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: RANDOMISED- DOUBLE BLINDED

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 26, 2018
• Study Start: March 22, 2018
• Primary Completion: November 1, 2021
• Study Completion: December 31, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

TU (1)