NCT05185401

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 23, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 22, 2021

Last Update Submit

February 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol

Study Arms (1)

non-Brugada population

Adult patients who underwent general anaesthesia (with propofol as induction agent) at the catheterisation laboratory of the UZ Brussel

Other: Observational study

Interventions

Retrospective data-analysis

non-Brugada population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who underwent a surgical procedure under propofol-based general anaesthesia in the CathLab of UZB.

You may qualify if:

  • Induction of anaesthesia with propofol
  • Monitored anaesthesia in the CathLab of the Universitair Ziekenhuis Brussel

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

February 1, 2022

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

February 23, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations