Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04580992
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2020-10-01
Brief Title:
Defining the Electrocardiographic Effect of Propofol on the Ajmaline Provocation Drug Challenge A Prospective Trial
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Defining the Electrocardiographic Effect of Propofol on the Ajmaline Provocation Drug Challenge A Prospective Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Brugada Syndrome is an inherited channelopathy associated with risk of ventricular fibrillation and sudden cardiac death in a structurally normal heart The diagnosis is based on the characteristic electrocardiographic pattern coved type STsegment elevation 2mm followed by a negative T-wave in one or more of the right precordial leads V1 to V2 noted spontaneously or upon administration of a sodiumchannel blocker such as Ajmaline
The majority of adults screened for Brugada Syndrome undergo the Ajmaline provocation-test awake Ajmaline is therefore injected continuously with incremental steps through an intravenous placed catheter according to cardiological protocols In a subpopulation of anxious adults or when another electrophysiological procedure is required at the same time sedation or general anaesthesia is provided Similarly in the paediatric population it is common practice to perform the challenge test under sedation
Based on the sodium channel blocking properties of propofol it is not unthinkable that anaesthetic agents might interact with the pharmacodynamic or pharmacokinetic effects of Ajmaline on the myocardial sodium channels Existence of such interaction would implicate altered diagnostic value of the Ajmaline-provocation-test for patients that undergo the challenge under general anaesthesia
Objective The goal of this study is to evaluate if the Ajmaline-provocation-test results in altered electrocardiographic effects when performed under general anaesthesia with propofol
Study-design A prospective observational study
Study population Patients are eligible for inclusion if they have been diagnosed with Brugada Syndrome are American Society of Anaesthesiologists ASA 2 - 4 older than 18 years and are scheduled for epicardial ablation Exclusion criteria are known allergy for propofol a body mass index BMI above 35 for female and 42 for male patients obstetric patients critical illness conditions that exclude continuous propofol infusion due to higher risk for propofol infusion syndrome PRIS such as mitochondrial disease fatty acid oxidation disorder co-enzyme Q deficiency and any other condition that renders the patient unfit for elective surgery
Intervention This study is prospective observational
Main study parametersendpoints The primary endpoints are changes in the ST- Jp- QRS- Tp-e-segments and Tp-eQT -ratio changes during steady-state anaesthesia The secondary endpoint is the occurrence of de novo arrhythmias
Nature and extent of the burden and risks associated with participation This is an observational study therefore the risks associated are no other than those associated with the intervention itself No additional blood-samples tests or consults are necessitated during participation therefore no extra burden is associated
The majority of adults screened for Brugada Syndrome undergo the Ajmaline provocation-test awake Ajmaline is therefore injected continuously with incremental steps through an intravenous placed catheter according to cardiological protocols In a subpopulation of anxious adults or when another electrophysiological procedure is required at the same time sedation or general anaesthesia is provided Similarly in the paediatric population it is common practice to perform the challenge test under sedation
Based on the sodium channel blocking properties of propofol it is not unthinkable that anaesthetic agents might interact with the pharmacodynamic or pharmacokinetic effects of Ajmaline on the myocardial sodium channels Existence of such interaction would implicate altered diagnostic value of the Ajmaline-provocation-test for patients that undergo the challenge under general anaesthesia
Objective The goal of this study is to evaluate if the Ajmaline-provocation-test results in altered electrocardiographic effects when performed under general anaesthesia with propofol
Study-design A prospective observational study
Study population Patients are eligible for inclusion if they have been diagnosed with Brugada Syndrome are American Society of Anaesthesiologists ASA 2 - 4 older than 18 years and are scheduled for epicardial ablation Exclusion criteria are known allergy for propofol a body mass index BMI above 35 for female and 42 for male patients obstetric patients critical illness conditions that exclude continuous propofol infusion due to higher risk for propofol infusion syndrome PRIS such as mitochondrial disease fatty acid oxidation disorder co-enzyme Q deficiency and any other condition that renders the patient unfit for elective surgery
Intervention This study is prospective observational
Main study parametersendpoints The primary endpoints are changes in the ST- Jp- QRS- Tp-e-segments and Tp-eQT -ratio changes during steady-state anaesthesia The secondary endpoint is the occurrence of de novo arrhythmias
Nature and extent of the burden and risks associated with participation This is an observational study therefore the risks associated are no other than those associated with the intervention itself No additional blood-samples tests or consults are necessitated during participation therefore no extra burden is associated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None