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Clinical Trials/NCT00700466
NCT00700466
Completed
Not Applicable

Beta-adrenoceptor Blockade Prior to Induction of Anesthesia for Improvement of Depressed Autonomic Regulation

University Hospital Schleswig-Holstein1 site in 1 country100 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
i.v. beta-blocker infusion (metoprolol)
Conditions
Hypertension
Sponsor
University Hospital Schleswig-Holstein
Enrollment
100
Locations
1
Primary Endpoint
Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
November 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Emergency cases
  • Myocardiac infraction within 4 weeks

Arms & Interventions

1

Patients with hypertension and/or tachycardia prior to induction of anesthesia requiring i.v. beta-blockade for treatment of raised hemodynamic

Intervention: i.v. beta-blocker infusion (metoprolol)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Hospital stay, one-year cardiac mortality and morbidity after discharge(Postoperatively until discharge, between discharge and 1 year after discharge)

Study Sites (1)

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