Status:
COMPLETED
The Influence of Age on EEG Signals and Consciousness During Anesthesia
Lead Sponsor:
Medtronic - MITG
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04765046
Start Date
August 18 2021
End Date
April 3 2023
Last Update
July 3 2024
Active Locations (2)
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1
Rambam Health Care Campus
Haifa, Israel
2
Leiden University Medical Center
Leiden, Netherlands