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

NCT04865614 | Completed

• 1 other identifier: COMPETENT
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Hypotension Drug-Induced

Outcome Measures

Primary Outcomes (1)

• Post-induction hypotension

  Hypotension in the first 20 minutes after induction of anesthesia

  First 20 minutes after induction of anaesthesia

Secondary Outcomes (2)

• Use of catecholamines after induction during the first 20 minutes after inductionafter induction

  First 20 minutes after induction

• Use of catecholamines

  Length of procedure (Approximately 60 to 90 minutes in average)

Study Arms (2)

Etomidate group

Patients who received etomidate for induction of anaesthesia during interventional mitral valve repair (Mitraclip)

Drug: Etomidate

Sevoflurane group

Patients who received sevoflurane for induction of anaesthesia during interventional mitral valve repair (Mitraclip)

Drug: Sevoflurane

Interventions

Etomidate DRUG

Use of etomidate

Etomidate group

Sevoflurane DRUG

Use of sevoflurane

Sevoflurane group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing interventional mitral valve repair

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Heidelberg University: lead
• University Hospital, Essen: collaborator

Study Sites (1)

Anästhesiologische Klinik (Universitätsklinikum Heidelberg)

Heidelberg, Baden-Würtemberg, 69120, Germany

Location

MeSH Terms

Conditions

Hypotension

Interventions

Etomidate; Sevoflurane

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Adrian E Stephan, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)