Clinical Effects Of Continuous Infusion Of Propofol In Adults With Brugada Syndrome.

Electrocardiographic And Clinical Effects Of Target-Controlled Infusion Of Propofol In Adults With Brugada Syndrome. A Pilot Study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004750-28-BE

Enrollment

Registered

2021-04-01

Start date

2021-04-30

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Target Controlled Infusion of Propofol in patients with Brugada Syndrome.

Interventions

Trade Name: Diprivan Product Name: Diprivan Product Code: SUB10116MIG Pharmaceutical Form: Injection INN or Proposed INN: Propofol Other descriptive name: PROPOFOL Concentration unit: % percent Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 year - ASA 2, 3 or 4 - Elective surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - Known allergy to propofol - Severe cerebral pathology - Ketamine administration - Nitrous Oxide administration - Successful performed locoregional block prior to surgery - 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 - Surgical site interference with 12-lead ECG site (e.g. chest surgery) - Ajmaline administration during surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: The goal of this pilot study is to evaluate the feasibility of the intended approach for the main research project, obtaining electrocardiographic information during the surgical procedure, investigating possible interferences during data acquisition. This pilot study should reveal any potential design issues or unexpected impediments in the protocol of the main future research project.;Secondary Objective: N/A;Primary end point(s): Qualitative data registration for ECG- and EEG-registration during surgery, rendering usable data for ecg- analysis;Timepoint(s) of evaluation of this end point: Readability of ECG registrations at the following time-point T0: Baseline electrocardiogram (ecg) (12-lead IC3&IC4) TWAV< 60: First ecg under anaesthesia when WAVCNS drops < 60 TMIN: ecg at minute 2, 4, 6, 10, 20, 30…and every ten minutes afterwards Discharge ecg prior to discharge from PACU (12-lead IC3&IC4) 24 hours Holter monitoring after discharge PACU	—

Measure

Time frame

Main Objective: The goal of this pilot study is to evaluate the feasibility of the intended approach for the main research project, obtaining electrocardiographic information during the surgical procedure, investigating possible interferences during data acquisition. This pilot study should reveal any potential design issues or unexpected impediments in the protocol of the main future research project.;Secondary Objective: N/A;Primary end point(s): Qualitative data registration for ECG- and EEG-registration during surgery, rendering usable data for ecg- analysis;Timepoint(s) of evaluation of this end point: Readability of ECG registrations at the following time-point T0: Baseline electrocardiogram (ecg) (12-lead IC3&IC4) TWAV< 60: First ecg under anaesthesia when WAVCNS drops < 60 TMIN: ecg at minute 2, 4, 6, 10, 20, 30…and every ten minutes afterwards Discharge ecg prior to discharge from PACU (12-lead IC3&IC4) 24 hours Holter monitoring after discharge PACU

—

Secondary

Measure	Time frame
Secondary end point(s): Eeg-data utilisation during surgery;Timepoint(s) of evaluation of this end point: Throughout the whole surgery. (95% of qualitative data)	—

Countries

Belgium

Contacts

Public ContactDepartment of Anesthesia

Universitair Ziekenhuis Brussel

panagiotis.flamee@uzbrussel.be+3224763143

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026