The Influence of Age on EEG Signals and Consciousness During Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Bispectral (BIS™) Complete Monitoring System

• Registration Number: NCT04765046
• Lead Sponsor: Medtronic - MITG

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.

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-08-18
• Primary Completion: 2023-04-03
• Study Completion: 2023-04-03
• Results First Submitted: 2024-01-08
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIS™ System	Bispectral (BIS™) Complete Monitoring System	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.

Primary Outcome Measures

Name	Time	Method
BIS50	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

Trial Locations

Locations (2)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands