Intravenous Beta-blockade for Improvement of Autonomic Activity

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00700466
First received: June 13, 2008
Last updated: January 15, 2010
Last verified: February 2009
  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 ] [ 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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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
outcome

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

ClinicalTrials.gov processed this record on August 28, 2014