E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intraoperative awareness during general anesthesia |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
By recording the EEG from participants before, during and after administration of low-dose propofol, it can be tested whether our system is able to reliably detect movements in the presence of low-dose anesthetic drugs. Thus, analyses should reveal whether under such conditions a clinically feasible true positive response can be obtained, while at the same time maintaining a clinically feasible false positive rate. |
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E.2.2 | Secondary objectives of the trial |
The brain responses between different conditions (absence and presence of low-dose anesthetic drugs) can be compared, possibly leading to new insights regarding the nature and robustness of movement-related EEG- changes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-18-65 years old -right-handed -normal or corrected to normal vision -normal or corrected to normal hearing |
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E.4 | Principal exclusion criteria |
-neurological impairment -motor disabilities -known allergies or oversensitivity to propofol -allergies to peanuts and/or soy -cardiac respiratory, renal or hepatic impairment -regular drug intake (of any kind, other than contraceptives and antihistamines) -pregnancy or nursing |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is the classification rate of our algorithm, i.e. the percentage of movement trials that are correctly classified as movement trials and the percentage of non-movement trials that are correctly classified as non-movement trials, as well as its underlying TPR/FPR tradeoff. Although for some applications speed may be prioritized over accuracy, for the current application it is important that false alarms are kept to an absolute minimum. By plotting a receiver operating characteristic (ROC) curve for the classifier output, it can be determined whether our required maximum FPR and minimum TPR can be obtained. From these calculations the time needed for a correct detection can also be determined. Although the algorithm is programmed in such a way that it can take into account any feature from the EEG that distinguishes between the two classes, we expect the main useful feature to be the combined Event-Related Desynchronization (ERD), a power decrease in the α- and β-frequency bands known to occur during (planning) of movement and Event-Related Synchronization (ERS), a power increase in approximately the same frequencies, known to occur after movement has stopped. These features have been well established in the literature and these findings have been replicated in our own lab. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After data collection and analysis for all subjects |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
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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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |