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Intravenous Beta-blockade for Improvement of Autonomic Activity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700466
First Posted: June 18, 2008
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Schleswig-Holstein
  Purpose

Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas amelioration of autonomic activity was demonstrated to be a major cause of outcome improvement. Therefore, perioperative beta-adrenoceptor blockade is recommended in patients with Revised Cardiac Risk Index score of three or greater. The investigators hypothesise that preoperative intravenous beta-adrenoceptor blockade for treatment of hypertension and/or tachycardia improves autonomic activity reflected by increase of Total Power of Heart Rate Variability.

Material and Methods: After IRB approval 20 patients scheduled for elective cardiac surgery were included into the study. Routine medication was continued throughout the study as recommended by the guidelines. HRV (TP and Low to High Frequency ratio (LF/HF) reflecting sympathetic to parasympathetic balance) was analysed prior to induction of general anesthesia and beta-adrenoceptor blockade in all patients (Baseline). Patients were assigned by their baseline hemodynamics. Patients with hypertension (systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg) or tachycardia (heart rate > 80bpm) were assigned to group BETA-BLOCK. In this group metoprolol-boli (2mg) were administered intravenously in stepwise manner until hemodynamic values decreased to normal. Total dosage was recorded. After normalisation of hemodynamics, second HRV analysis was performed (Intervention). Normotensive and normocardic patients were assigned to group CONTROL. No intervention was performed. Statistics: Mann Whitney U test for comparison between groups and between events Baseline and Intervention within group BETA-BLOCK, p<0.05.


Condition Intervention
Hypertension Tachycardia Heart Rate Variability Drug: i.v. beta-blocker infusion (metoprolol)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beta-adrenoceptor Blockade Prior to Induction of Anesthesia for Improvement of Depressed Autonomic Regulation

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade [ Time Frame: Baseline, after i.v. beta-blockade, 6 months after discharge ]

Secondary Outcome Measures:
  • Hospital stay, one-year cardiac mortality and morbidity after discharge [ Time Frame: Postoperatively until discharge, between discharge and 1 year after discharge ]

Estimated Enrollment: 100
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with hypertension and/or tachycardia prior to induction of anesthesia requiring i.v. beta-blockade for treatment of raised hemodynamic
Drug: i.v. beta-blocker infusion (metoprolol)
A beta-blocker (metoprolol) will be infused for treatment of hypertension and/or tachycardia prior to induction of anesthesia aiming at decrease of blood pressure and heart rate to normal limits
Other Name: Metorpolol, Lopresor(R)
2
Patients with normal hemodynamic values prior to induction of anesthesia not requiring treatment

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for coronary artery bypass surgery
Criteria

Inclusion Criteria:

  • Patients scheduled for coronary artery bypass surgery
  • Ejection fraction > 30 %
  • Informed consent

Exclusion Criteria:

  • Emergency cases
  • Myocardiac infraction within 4 weeks
  Contacts and Locations
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): NCT00700466


Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel, Germany
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Robert Hanss, MD Consultant in Anesthesiology, Dep. of Anesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Germany
  More Information

Responsible Party: Jens Scholz, Chair of the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Germany
ClinicalTrials.gov Identifier: NCT00700466     History of Changes
Other Study ID Numbers: Hanss_EA 162/07
First Submitted: June 13, 2008
First Posted: June 18, 2008
Last Update Posted: January 18, 2010
Last Verified: February 2009

Keywords provided by University of Schleswig-Holstein:
Outcome assessment, patients;
autonomic nervous system;
perioperative care;
adrenergic beta antagonist
Autonomic regulation
Perioperative beta-blockade
outcome

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Metoprolol
Adrenergic beta-Antagonists
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action