Intraoperative awareness during general anesthesia
Conditions
Interventions
Trade Name: Rocuroniumbromide Fresenius Kabi 10 mg/ml
Product Name: Rocuroniumbromide
Pharmaceutical Form: Injection
INN or Proposed INN: Rocuroniumbromide Fresenius Kabi 10 mg/ml
CAS Number: 119302-9
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -18-65 years old -right-handed -normal or corrected to normal vision -normal or corrected to normal hearing 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -neurological impairment -motor disabilities -known allergies to Rocuronium and/or Sugammadex -regular drug intake -hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The brain responses between different conditions (actual movement, imagined movement, isometric movement and attempted (blocked) movement) can be compared, possibly leading to new insights regarding the nature and underlying processes of movement-related EEG-changes. ;Main Objective: We hypothesize that attempted but pharmacologically blocked movement can be detected from EEG (i.e., with a classification rate higher than chance), possibly as well as imagined movement or even isometric movement. By recording the EEG from participants instructed to attempt hand movement even though motor output is blocked, it can be tested whether our system is able to reliably detect these attempted movements. ;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. 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 a- and ß-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. ;Timepoint(s) of evaluation of this end point: After data collection and analysis for all subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As also EMG and the level of neuromuscular blockade (train-of four monitoring) will be measured throughout the experiment, insight might be gained into the influence of Rocuronium on EMG and the level of neuromuscular blockade (train-of four monitoring) and the interplay between them.;Timepoint(s) of evaluation of this end point: After data collection and analysis for all subjects | — |
Countries
Netherlands
Outcome results
None listed