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

May 7, 2021 updated by: mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34865
        • Mustafa Emre Gurcu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 24 hours
Low and high frequency of heart rate regarding with aritmia incidence
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2018

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/3/53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Effect of Sedation on Heart Rate Variability

Clinical Trials on Precedex 200 MCG in 2 ML Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe