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Intravenous Beta-blockade for Improvement of Autonomic Activity

This study has been completed.
Information provided by:
University of Schleswig-Holstein Identifier:
First received: June 13, 2008
Last updated: January 15, 2010
Last verified: February 2009

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
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
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)
Patients with normal hemodynamic values prior to induction of anesthesia not requiring treatment


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency cases
  • Myocardiac infraction within 4 weeks
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Please refer to this study by its identifier: NCT00700466

University Hospital Schleswig-Holstein, Campus Kiel, Germany
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
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 Identifier: NCT00700466     History of Changes
Other Study ID Numbers: Hanss_EA 162/07 
Study First Received: June 13, 2008
Last Updated: January 15, 2010
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016