N/A
N=90
The Influence of Age on EEG Signals and Consciousness During Anesthesia
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04765046 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: BIS50 — 70.9; 74.7 index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bispectral (BIS™) Complete Monitoring System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BIS50 |
70.9; 74.7 | — |
Summary
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.
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
Data sourced from ClinicalTrials.gov (NCT04765046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.