Left Ventricular Diastolic Function During Anesthesia Induction

March 10, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled for surgery under general anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sevoflurane
Anesthesia maintenance
Drug: Sevoflurane
Anesthesia maintenance with Sevoflurane
Propofol
Anesthesia maintenance
Drug: Propofol
Anesthesia maintenance with Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Norepinephrine
Time Frame: 30 minutes after induction of anesthesia
Cumulative dose of norepinephrine (adjusted for body weight) during the first 30 minutes after induction of anesthesia
30 minutes after induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
e'
Time Frame: Directly after induction of anesthesia
Change of the echocardiographic tissue doppler parameter e' after induction of anesthesia
Directly after induction of anesthesia
E / e'
Time Frame: Directly after induction of anesthesia
Change of the echocardiographic index of transmitral flow and tissue doppler after induction of anesthesia
Directly after induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Katharina Roeher, Dr. med., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

September 27, 2018

Study Completion (ACTUAL)

September 27, 2018

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (ACTUAL)

May 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV 5436

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe