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

• Sponsor: Heidelberg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04865614
• Collaborator: University Hospital, Essen (Other)
• Enrollment: 57
• Location: 1
• Actual Duration (Months): 20
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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	Phase
Blood Pressure; Hypotension Drug-Induced	Drug: Etomidate; Drug: Sevoflurane

Study Design

• 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: Apr 1, 2019
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Post-induction hypotension [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 [First 20 minutes after induction]

   Use of catecholamines during the first 20 minutes after induction of anaesthesia

2. Use of catecholamines [Length of procedure (Approximately 60 to 90 minutes in average)]

   Use of catecholamines during the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Anästhesiologische Klinik (Universitätsklinikum Heidelberg)	Heidelberg	Baden-Würtemberg	Germany	69120

Sponsors and Collaborators

• Heidelberg University
• University Hospital, Essen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Adrian Stephan, Principal Investigator, Heidelberg University
• ClinicalTrials.gov Identifier: NCT04865614
• Other Study ID Numbers: COMPETENT
• First Posted: Apr 29, 2021
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension; Sevoflurane; Etomidate

Study Results

No Results Posted as of Oct 26, 2021