The influence of age on EEG signals and consciousness during anesthesia (TIARA)

Completed

Conditions: De invloed van leeftijd op EEG signalen en bewustzijn tijdens anesthesie
consciousness during anesthesia
EEG signals

Registration Number: NL-OMON54342

Lead Sponsor: Medtronic Trading NL BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective(s)<br /><br>To evaluate the relationships between BIS parameters, age, and depth of<br /><br>anesthesia in patients undergoing surgery under general anesthesia.<br /><br><br /><br><br /><br>Primary Endpoint<br /><br>All data gathered by the BIS* system during general anesthesia, including:<br /><br><br /><br>* EEG waveforms<br /><br>* EMG<br /><br>* BIS Number<br /><br>* Total Power<br /><br>* Anesthesia records</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s)<br /><br>To investigate BIS parameters, depth of anesthesia and physical and cognitive<br /><br>states in the study subject population.<br /><br><br /><br><br /><br>Secondary Endpoint<br /><br><br /><br>Assessments of the subjects demographics, age and blood panel as well as the<br /><br>physical and cognitive state using:<br /><br><br /><br> Mini Mental State Examination (MMSE)<br /><br>* Mini Nutritional Assessment (MNA®-SF)<br /><br>* Edmonton Frail Scale (EFS)</p><br>