Intravenous Beta-blockade for Improvement of Autonomic Activity
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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 |
- 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 ]
- 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 |
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
Contacts and Locations| Germany | |
| University Hospital Schleswig-Holstein, Campus Kiel, Germany | |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| 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 May 23, 2013