Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Left Ventricular Diastolic Function During Anesthesia Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522194
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Condition or disease Intervention/treatment
Left Ventricular Diastolic Dysfunction Drug: Sevoflurane Drug: Propofol

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Left Ventricular Diastolic Function on Hemodynamic Stability During Anesthesia Induction and on Postoperative Complications
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort Intervention/treatment
Sevoflurane
Anesthesia maintenance
Drug: Sevoflurane
Anesthesia maintenance with Sevoflurane

Propofol
Anesthesia maintenance
Drug: Propofol
Anesthesia maintenance with Propofol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. e' [ Time Frame: Directly after induction of anesthesia ]
    Change of the echocardiographic tissue doppler parameter e' after induction of anesthesia

  2. E / e' [ Time Frame: Directly after induction of anesthesia ]
    Change of the echocardiographic index of transmitral flow and tissue doppler after induction of anesthesia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled for surgery under general anesthesia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522194


Locations
Layout table for location information
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Layout table for investigator information
Principal Investigator: Katharina Roeher, Dr. med. Universitätsklinikum Hamburg-Eppendorf
Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03522194    
Other Study ID Numbers: PV 5436
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation