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

Medtronic

Status: Completed

Conditions: Anesthesia

Treatments: Device: Bispectral (BIS™) Complete Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04765046

MDT18067TIARA

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A potential subject may be included for participation in the study if the subject has/is:

1. ≥18 years of age
2. American Society of Anesthesiologists (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 >2 hours

Exclusion criteria

A potential subject will be excluded from participating in the study if the subject has/is:

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

BIS™ System

Other group

Description:

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.

Treatment:

Device: Bispectral (BIS™) Complete Monitoring System