Anesthesia
Conditions
Keywords
Bispectral index
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.
Interventions
DEVICEBispectral (BIS™) Complete Monitoring System
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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIS™ 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.
Bispectral (BIS™) Complete Monitoring System: 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. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
| Overall Study | Screen Failure | 2 |
| Overall Study | Surgery Cancelled | 8 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | BIS™ System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 28 Participants | — |
| Age, Categorical Between 18 and 65 years | 29 Participants | — |
| Age, Continuous | 59.4 years STANDARD_DEVIATION 17.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 33 |
| other Total, other adverse events | 0 / 39 | 0 / 33 |
| serious Total, serious adverse events | 0 / 39 | 0 / 33 |
Outcome results
Primary
BIS50
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
Time frame: 8 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Age 18-64 | BIS50 | 70.9 index |
| Age 65+ | BIS50 | 74.7 index |