No Specific Condition (Patients Without Brugada Syndrome)Prop STNCT05185401
Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG
An observational study of No Specific Condition (Patients Without Brugada Syndrome), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the effect of propofol induced general anaesthesia on the ST-segment of the electrocardiogram. This will be realised by retrospectively analysing the ECG-recordings from adult patients undergoing any treatment at the Catheterisation Laboratory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Specific Condition (Patients Without Brugada Syndrome)
- What is being tested?
- Observational study
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2022to Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent a surgical procedure under propofol-based general anaesthesia in the CathLab of UZB.
Who may be able to join
- Induction of anaesthesia with propofol
- Monitored anaesthesia in the CathLab of the Universitair Ziekenhuis Brussel
Who cannot join
- Brugada Syndrome or family history of Brugada syndrome
- Paediatric population (age <18)
- Patients who did not receive propofol during the procedure
- Patients who presented with fever (central core temperature >38,0°C)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
About this study
The purpose of this study is to assess the effect of propofol induced general anaesthesia on the ST-segment of the electrocardiogram. This will be realised by retrospectively analysing the ECG-recordings from adult patients undergoing any treatment at the Catheterisation Laboratory. The ST-segment and other ECG measurements from induction of anaesthesia up to 20 minutes later, will be assessed and compared to the baseline values of the respective segments acquired before injecting propofol. It is essential in this study to exclude any patients burdened with the diagnosis, suspicion or family history of Brugada syndrome.
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Retrospective data-analysis
| Study group | Role | What they receive |
|---|---|---|
| non-Brugada population | Adult patients who underwent general anaesthesia (with propofol as induction agent) at the catheterisation laboratory of the UZ Brussel Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST-segment variations after propofol administration.
Determine ST-segment variations in mm (either augmentation or suppression) on the ECG in the 20 minute period after administration of propofol in comparison to the baseline ECG
Measured: Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol
Secondary outcomes (1)
Additional ECG-segment variations after propofol administration
Assess additional ECG-segments measurements in mm and ms from the ECGs recorded. These include Jp- (mm), QRS- (ms), T(p-e)-segments (ms) and the T(p-e)/QT ratio.
Measured: Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific Condition (Patients Without Brugada Syndrome)Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185401
- Sponsor's protocol ID
- Prop ST-Segment
- Acronym
- Prop ST
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 23 Feb 2022
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG
- ClinicalTrials.gov ID
- NCT05185401
- Acronym / sponsor ID
- Prop ST / Prop ST-Segment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Jan 2022 (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 purpose of this study is to assess the effect of propofol induced general anaesthesia on the ST-segment of the electrocardiogram. This will be realised by retrospectively analysing the ECG-recordings from adult patients undergoing any treatment at the Catheterisation Laboratory. The ST-segment and other ECG measurements from induction of anaesthesia up to 20 minutes later, will be assessed and compared to the baseline values of the respective segments acquired before injecting propofol. It is essential in this study to exclude any patients burdened with the diagnosis, suspicion or family history of Brugada syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-Brugada population | – | Other: Observational studyAdult patients who underwent general anaesthesia (with propofol as induction agent) at the catheterisation laboratory of the UZ Brussel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent a surgical procedure under propofol-based general anaesthesia in the CathLab of UZB.
Key inclusion criteria (2 listed)
- Induction of anaesthesia with propofol
- Monitored anaesthesia in the CathLab of the Universitair Ziekenhuis Brussel
Key exclusion criteria (4 listed)
- Brugada Syndrome or family history of Brugada syndrome
- Paediatric population (age <18)
- Patients who did not receive propofol during the procedure
- Patients who presented with fever (central core temperature >38,0°C)
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 |
|---|---|---|
| Observational studyRetrospective data-analysis | Other | non-Brugada population |
Primary outcome
ST-segment variations after propofol administration.
Time frame: Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol
Determine ST-segment variations in mm (either augmentation or suppression) on the ECG in the 20 minute period after administration of propofol in comparison to the baseline ECG
1 secondary outcome
Additional ECG-segment variations after propofol administration
Time frame: Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 No Specific Condition (Patients Without Brugada Syndrome), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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 Belgium. 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?
Results are not available in the source record.
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?
ST-segment variations after propofol administration. (time frame: Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol). 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 23 Feb 2022.