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NCT Number: NCT04765046

The Influence of Age on EEG Signals and Consciousness During Anesthesia

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bispectral (BIS™) Complete Monitoring System

Device

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.

Primary outcomes

  1. BIS50

    Time frame: 8 hours

    The Bispectral Index (BIS) value, a scale 0-100 with 0 being no brain activity and 100 being fully conscious, at which 50% of subjects are anesthetized at a level they are considered uncounscious based on the MOAA/S score of 0-2

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: TIARA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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