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NCT03522194 Clinical Trial

Left Ventricular Diastolic Function During Anesthesia Induction

Left Ventricular Diastolic Dysfunction Clinical Trial

Official title:
Influence of Left Ventricular Diastolic Function on Hemodynamic Stability During Anesthesia Induction and on Postoperative Complications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03522194
Other study ID # PV 5436
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date September 27, 2018

Study information
Verified date March 2019
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. The impact of different anesthetics on diastolic function is investigated.

Description:

In this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. Anesthesia is maintained with sevoflurane or propofol. Before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. Immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. All anesthetic medications, fluids, vasoactive medications and catecholamines are registered.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 27, 2018
Est. primary completion date September 27, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Patients older than 60 years scheduled for general anesthesia

Exclusion Criteria:

- Mitral regurgitation or stenosis > I°

- Sp. mitral valve repair or replacement

- Pericardial effusion

- Atrial fibrillation/flutter

- Patients with pacemaker

- BMI > 35 kg/m2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sevoflurane
Anesthesia maintenance with Sevoflurane
• Propofol
Anesthesia maintenance with Propofol

Locations
Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Norepinephrine Cumulative dose of norepinephrine (adjusted for body weight) during the first 30 minutes after induction of anesthesia 30 minutes after induction of anesthesia
Secondary e' Change of the echocardiographic tissue doppler parameter e' after induction of anesthesia Directly after induction of anesthesia
Secondary E / e' Change of the echocardiographic index of transmitral flow and tissue doppler after induction of anesthesia Directly after induction of anesthesia
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