Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG (Prop ST)

February 4, 2022 updated by: Universitair Ziekenhuis Brussel
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels
      • Brussel, Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Retrospective data-analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2022

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prop ST-Segment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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