Trial Outcomes & Findings for The Influence of Age on EEG Signals and Consciousness During Anesthesia (NCT NCT04765046)

NCT ID: NCT04765046

Last Updated: 2024-07-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2024-07-03

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	90
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	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.
Overall Study Screen Failure	2
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	4
Overall Study Surgery Cancelled	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	BIS™ System n=57 Participants 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.
Age, Categorical <=18 years	0 Participants n=57 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=57 Participants
Age, Categorical >=65 years	28 Participants n=57 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 17.5 • n=57 Participants
Sex: Female, Male Female	29 Participants n=57 Participants
Sex: Female, Male Male	28 Participants n=57 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Age 18-64 n=29 Participants Subjects enrolled aged 18-64	Age 65+ n=28 Participants Subjects enrolled aged 65 and older
BIS50	70.9 index Interval 67.8 to 73.7	74.7 index Interval 72.0 to 77.1

Adverse Events

Age 18-64

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Age 65+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ami Stuart

Medtronic

Phone: 8017934800

Email: ami.stuart@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place