Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair (COMPETENT)

October 25, 2021 updated by: Dr. Adrian Stephan, Heidelberg University

The induction of anaesthesia is one of the most critical situations for high-risk-patients undergoing interventions surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This retrospective cohort study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of catecholamines during the induction and the interventional procedure in patients undergoing interventional mitral valve repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

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
    • Baden-Würtemberg
      • Heidelberg, Baden-Würtemberg, Germany, 69120
        • Anästhesiologische Klinik (Universitätsklinikum Heidelberg)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing interventional mitral valve repair

Description

Inclusion Criteria:

  • Patients undergoing elective interventional mitral valve repair
  • Sevoflurane or etomidate have been used for induction of anesthesia

Exclusion Criteria:

  • Pregnancy

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
Etomidate group
Patients who received etomidate for induction of anaesthesia during interventional mitral valve repair (Mitraclip)
Drug: Etomidate
Use of etomidate
Sevoflurane group
Patients who received sevoflurane for induction of anaesthesia during interventional mitral valve repair (Mitraclip)
Drug: Sevoflurane
Use of sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-induction hypotension
Time Frame: First 20 minutes after induction of anaesthesia
Hypotension in the first 20 minutes after induction of anesthesia
First 20 minutes after induction of anaesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of catecholamines after induction during the first 20 minutes after inductionafter induction
Time Frame: First 20 minutes after induction
Use of catecholamines during the first 20 minutes after induction of anaesthesia
First 20 minutes after induction
Use of catecholamines
Time Frame: Length of procedure (Approximately 60 to 90 minutes in average)
Use of catecholamines during the procedure
Length of procedure (Approximately 60 to 90 minutes in average)

Collaborators and Investigators

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

Sponsor

Heidelberg University

Collaborators

University Hospital, Essen

Investigators

  • Principal Investigator: Adrian E Stephan, MD, Heidelberg University

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, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPETENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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