De invloed van leeftijd op EEG signalen en bewustzijn tijdens anesthesie consciousness during anesthesia EEG signals
Conditions
Interventions
Subjects will be considered enrolled at the time they sign the informed
consent. Basic demographic and Medical History data will be collected at the
baseline visit, and subjects will be given three
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. >=18 years of age 2. ASA physical status I-III 3. Able and willing to participate in the study and sign the informed consent form 4. Will undergo non-ambulatory elective surgery under general anesthesia 5. Has an expected surgery time >1 hour
Exclusion criteria
Exclusion criteria: 1. Pregnant 2. Unwilling to undergo EEG measurement 3. Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years 4. Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages. 5. Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring) 6. Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression 7. Severe visual or auditory disorder 8. Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective(s) To evaluate the relationships between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia. Primary Endpoint All data gathered by the BIS* system during general anesthesia, including: * EEG waveforms * EMG * BIS Number * Total Power * Anesthesia records | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s) To investigate BIS parameters, depth of anesthesia and physical and cognitive states in the study subject population. Secondary Endpoint Assessments of the subject*s demographics, age and blood panel as well as the physical and cognitive state using: * Mini Mental State Examination (MMSE) * Mini Nutritional Assessment (MNA®-SF) * Edmonton Frail Scale (EFS) | — |
Countries
Netherlands
Outcome results
None listed