E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Target Controlled Infusion of Propofol in patients with Brugada Syndrome. |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 18 year - ASA 2, 3 or 4 - Elective surgery
|
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Qualitative data registration for ECG- and EEG-registration during surgery, rendering usable data for ecg- analysis |
|
E.5.1.1 | 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 |
|
E.5.2 | Secondary end point(s) |
Eeg-data utilisation during surgery |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the whole surgery. (95% of qualitative data) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
This is a pilot study of the subsequent prospective study that is planned afterwards |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |