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

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: NCT04865614
Recruitment Status : Completed
First Posted : April 29, 2021
Last Update Posted : October 26, 2021
Sponsor:
Collaborator:
University Hospital, Essen
Information provided by (Responsible Party):
Dr. Adrian Stephan, Heidelberg University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Blood Pressure Hypotension Drug-Induced Drug: Etomidate Drug: Sevoflurane

Study Design
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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Post-induction hypotension [ Time Frame: First 20 minutes after induction of anaesthesia ]
    Hypotension in the first 20 minutes after induction of anesthesia


Secondary Outcome Measures :
  1. 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

  2. Use of catecholamines [ Time Frame: Length of procedure (Approximately 60 to 90 minutes in average) ]
    Use of catecholamines during the procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing interventional mitral valve repair
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
Contacts and Locations
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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): NCT04865614


Locations
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Germany
Anästhesiologische Klinik (Universitätsklinikum Heidelberg)
Heidelberg, Baden-Würtemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
University Hospital, Essen
Investigators
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Principal Investigator: Adrian E Stephan, MD Heidelberg University
More Information
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Responsible Party: Dr. Adrian Stephan, Principal Investigator, Heidelberg University
ClinicalTrials.gov Identifier: NCT04865614    
Other Study ID Numbers: COMPETENT
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Sevoflurane
Etomidate
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous