Intravenous Beta-Blockade for Improvement of Autonomic Activity
Information source: University of Schleswig-Holstein
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Tachycardia; Heart Rate Variability
Intervention: i.v. beta-blocker infusion (metoprolol) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Schleswig-Holstein Official(s) and/or principal investigator(s):
Robert Hanss, MD, Principal Investigator, Affiliation: Consultant in Anesthesiology, Dep. of Anesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Germany
Overall contact:
Robert Hanss, MD, Phone: ++49 (0) 431 5972990, Email: hanss@anaesthesie.uni-kiel.de
Summary
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.
Clinical Details
Official title: Beta-Adrenoceptor Blockade Prior to Induction of Anesthesia for Improvement of Depressed Autonomic Regulation
Study design: Cohort, Prospective
Primary outcome: Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade
Secondary outcome: Hospital stay, one-year cardiac mortality and morbidity after discharge
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients scheduled for coronary artery bypass surgery
- Ejection fraction > 30 %
- Informed consent
Exclusion Criteria:
- Emergency cases
- Myocardiac infraction within 4 weeks
Locations and Contacts
Robert Hanss, MD, Phone: ++49 (0) 431 5972990, Email: hanss@anaesthesie.uni-kiel.de
University Hospital Schleswig-Holstein, Campus Kiel, Germany, Kiel, Schleswig-Holstein 24105, Germany; Recruiting
Berthold Bein, MD, Phone: ++49 (0) 431 5972971, Email: bein@anaesthesie.uni-kiel.de
Martin Bauer, MD, Phone: ++49 (0) 431 59723694, Email: bauer@anaesthesie.uni-kiel.de
Robert Hanss, MD, Principal Investigator
Additional Information
Starting date: March 2008
Ending date: April 2009
Last updated: February 26, 2009
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