Intravenous Beta-blockade for Improvement of Autonomic Activity

Completed

• Conditions: Hypertension; Tachycardia; Heart Rate Variability
• Interventions: Drug: i.v. beta-blocker infusion (metoprolol)

• Registration Number: NCT00700466
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Status Verified: 2009-02
• Primary Completion: 2009-03
• Study Completion: 2009-11
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Emergency cases
• Myocardiac infraction within 4 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	i.v. beta-blocker infusion (metoprolol)	Patients with hypertension and/or tachycardia prior to induction of anesthesia requiring i.v. beta-blockade for treatment of raised hemodynamic

Primary Outcome Measures

Name	Time	Method
Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade	Baseline, after i.v. beta-blockade, 6 months after discharge

Secondary Outcome Measures

Name	Time	Method
Hospital stay, one-year cardiac mortality and morbidity after discharge	Postoperatively until discharge, between discharge and 1 year after discharge

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel, Germany; 🇩🇪 Kiel, Schleswig-Holstein, Germany