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

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05185401
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 1.9
• Patients Per Site Per Month: 257.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
No Specific Condition (Patients Without Brugada Syndrome)	Other: Observational study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. ST-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]

   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

Secondary Outcome Measures

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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Brussel	Brussels	Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT05185401
• Other Study ID Numbers: Prop ST-Segment
• First Posted: Jan 11, 2022
• Last Update Posted: Feb 23, 2022
• Last Verified: Dec 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: Brugada Syndrome

Study Results

No Results Posted as of Feb 23, 2022