NCT03522194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

April 30, 2018

Last Update Submit

March 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • e'

    Directly after induction of anesthesia

  • E / e'

    Directly after induction of anesthesia

Study Arms (2)

Sevoflurane

Anesthesia maintenance

Drug: Sevoflurane

Propofol

Anesthesia maintenance

Drug: Propofol

Interventions

Anesthesia maintenance with Sevoflurane

Sevoflurane

Anesthesia maintenance with Propofol

Propofol

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for surgery under general anesthesia

You may qualify if:

  • Patients older than 60 years scheduled for general anesthesia

You may not qualify if:

  • Mitral regurgitation or stenosis \> I°
  • Sp. mitral valve repair or replacement
  • Pericardial effusion
  • Atrial fibrillation/flutter
  • Patients with pacemaker
  • BMI \> 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Kahl U, Vens M, Pollok F, Menke M, Duckstein C, Gruetzmacher J, Schirren L, Yu Y, Fischer M, Zollner C, Goepfert MS, Roeher K. Do Elderly Patients With Diastolic Dysfunction Require Higher Doses of Norepinephrine During General Anesthesia for Noncardiac Surgeries? A Prospective Observational Study. Anesth Analg. 2021 Feb 1;132(2):420-429. doi: 10.1213/ANE.0000000000005304.

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Katharina Roeher, Dr. med.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

April 1, 2017

Primary Completion

September 27, 2018

Study Completion

September 27, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations