Defining the Electrocardiographic Effect of Propofol on the Ajmaline Provocation Drug Challenge: A Prospective Trial

NCT04580992 | Unknown FDA Drug

• 1 other identifier: APA Brugada study
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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 parameters/endpoints: The primary endpoints are changes in the ST-, Jp-, QRS-, T(p-e)-segments and T(p-e)/QT -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.

Conditions

Brugada Syndrome; Channelopathies; Ventricular Fibrillation; Cardiac Death

Outcome Measures

Primary Outcomes (1)

• ST-, QRS-, Jp-, QT-, QTcB-, QTcFr- and JT-interval

  Ventricular Arrhythmogenesis

  during the intervention/procedure/surgery

Secondary Outcomes (1)

• Malignant arrhythmias

  intra- or postoperatively (up to 24hours upon discharge from the post anaesthetic care unit)

Study Arms (1)

Ajmaline group

Drug: Ajmaline

Interventions

Ajmaline DRUG

Ajmaline administration

Ajmaline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are eligible for inclusion upon the age of 18, diagnosed with Brugada Syndrome and when epicardial ablation was indicated as treatment. In this study, we would like to include at least twenty-five patients.

You may qualify if:

• Age \>= 18 year
• ASA 2, 3, 4
• Epicardial ablation indicated by cardiologist
• Written informed consent

You may not qualify if:

• A known allergy to propofol
• BMI\>35 for female patients
• BMI \> 42 for male patients
• Obstetric anaesthesia
• Critical Illness
• Mitochondrial disease
• Fatty acid oxidation disorder
• Co-enzyme Q deficiency
• Any condition that renders the patient unfit for elective surgery

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussels

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Brugada Syndrome; Channelopathies; Ventricular Fibrillation; Death

Interventions

Ajmaline

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Evelien Vandeurzen

CONTACT

024749237; evelien.vandeurzen@uzbrussel.be

Dirk De Clippeleir

CONTACT

dirk.declippeleir@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 9, 2020
• Study Start: November 16, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-09

Locations

BE (1)