The Influence of Age on EEG Signals and Consciousness During Anesthesia

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.

Detailed Description
-----------------
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.

Official Title
-----------------
The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: Bispectral (BIS™) Complete Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A potential subject may be included for participation in the study if the subject has/is: ≥18 years of age American Society of Anesthesiologists (ASA) physical status I-III Able and willing to participate in the study and sign the informed consent form Will undergo non-ambulatory elective surgery under general anesthesia Has an expected surgery time >2 hours Exclusion Criteria: A potential subject will be excluded from participating in the study if the subject has/is: Pregnant Unwilling to undergo EEG measurement Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years 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. Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring) Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression Severe visual or auditory disorder Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BIS™ System<br>Enrolled subjects who are undergoing a standard of care elective surgery under general anesthesia, will be equipped with the BIS system to non-invasively measure and interpret brain waive activity directly related to the effects of anesthetic agents during the surgery duration. | Device: Bispectral (BIS™) Complete Monitoring System<br>* The BIS™ Complete Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS Parameter | To determine the relationship between the BIS number, age, depth of anesthesia | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bispectral index