Blood PressureCOMPETENTNCT04865614
Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair
An observational study of Blood Pressure and Hypotension Drug-Induced, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Hypotension Drug-Induced
- What is being tested?
- Etomidate and Sevoflurane
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing interventional mitral valve repair
Who may be able to join
- Patients undergoing elective interventional mitral valve repair
- Sevoflurane or etomidate have been used for induction of anesthesia
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Anästhesiologische Klinik (Universitätsklinikum Heidelberg)
Heidelberg, Baden-Würtemberg, 69120
About this study
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
- Being tested
- Etomidate, Sevoflurane
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Use of etomidate
SevofluraneDrug
Use of sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Etomidate group | Patients who received etomidate for induction of anaesthesia during interventional mitral valve repair (Mitraclip) Receives: Drug: Etomidate | |
| Sevoflurane group | Patients who received sevoflurane for induction of anaesthesia during interventional mitral valve repair (Mitraclip) Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction hypotension
Hypotension in the first 20 minutes after induction of anesthesia
Measured: First 20 minutes after induction of anaesthesia
Secondary outcomes (2)
Use of catecholamines after induction during the first 20 minutes after inductionafter induction
Use of catecholamines during the first 20 minutes after induction of anaesthesia
Measured: First 20 minutes after induction
Use of catecholamines
Use of catecholamines during the procedure
Measured: Length of procedure (Approximately 60 to 90 minutes in average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Apr 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Essen
- Responsible party
- Principal investigator, Dr. Adrian Stephan, Heidelberg University
- Investigators
- Adrian E Stephan, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865614
- Sponsor's protocol ID
- COMPETENT
- Acronym
- COMPETENT
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT04865614
- Acronym / sponsor ID
- COMPETENT / COMPETENT
- Conditions
- Blood Pressure, Hypotension Drug-Induced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Essen
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate group | – | Drug: EtomidatePatients who received etomidate for induction of anaesthesia during interventional mitral valve repair (Mitraclip) |
| Sevoflurane group | – | Drug: SevofluranePatients who received sevoflurane for induction of anaesthesia during interventional mitral valve repair (Mitraclip) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing interventional mitral valve repair
Key inclusion criteria (2 listed)
- Patients undergoing elective interventional mitral valve repair
- Sevoflurane or etomidate have been used for induction of anesthesia
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtomidateUse of etomidate | Drug | Etomidate group |
| SevofluraneUse of sevoflurane | Drug | Sevoflurane group |
Primary outcome
Post-induction hypotension
Time frame: First 20 minutes after induction of anaesthesia
Hypotension in the first 20 minutes after induction of anesthesia
2 secondary outcomes
Use of catecholamines after induction during the first 20 minutes after inductionafter induction
Time frame: First 20 minutes after induction
Use of catecholamines
Time frame: Length of procedure (Approximately 60 to 90 minutes in average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian E Stephan, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Hypotension Drug-Induced, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-induction hypotension (time frame: First 20 minutes after induction of anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.