Trial Outcomes & Findings for EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia (NCT NCT01543633)

Results Overview

We used EEG measurements to study the dynamics of loss of consciousness, auditory processing, sensation, and memory under general anesthesia induced with propofol. The EEG data in each of the three specific aims will be analyzed using spectral methods, source localization, and event-related potentials. Through spectral analysis, EEG power (in decibels) in alpha, slow, and delta bands are measured.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

11 hours

Results posted on

2022-01-11

Participant Flow

Subjects with abnormal cardiological abnormality, failure of the hearing test, abnormal ECG reading, and other medical conditions were excluded. Ten subjects also voluntarily withdrawn consent due to scheduling conflicts.

Participant milestones

Participant milestones
Measure	Active Study Arm Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli. Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
Overall Study STARTED	36
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Study Arm n=36 Participants Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli. Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
Age, Continuous	27 Years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 11 hours

We used EEG measurements to study the dynamics of loss of consciousness, auditory processing, sensation, and memory under general anesthesia induced with propofol. The EEG data in each of the three specific aims will be analyzed using spectral methods, source localization, and event-related potentials. Through spectral analysis, EEG power (in decibels) in alpha, slow, and delta bands are measured.

Outcome measures

Outcome measures
Measure	Active Study Arm n=17 Participants Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli. Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
EEG Power in Alpha, Slow, and Delta Bands Alpha Band Power	10 Power of alpha band (decibels) Interval 8.0 to 12.0
EEG Power in Alpha, Slow, and Delta Bands Slow Band Power	0.55 Power of alpha band (decibels) Interval 0.1 to 1.0
EEG Power in Alpha, Slow, and Delta Bands Delta Band Power	2.5 Power of alpha band (decibels) Interval 1.0 to 4.0

Adverse Events

Active Study Arm

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

Dr. Emery N. Brown

Neuroscience Statistics Research Laboratory, Massachusetts General Hospital

Phone: (617) 726-8786

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place