EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia

The purpose of this study is to investigate how the commonly used anesthetic drug propofol works in the brain to produce loss of consciousness. While under general anesthesia your brain waves will be measured using electroencephalogram (EEG). On a separate day, the patient's brain will be imaged using magnetic resonance imaging (MRI).

Study Overview

• Status: Completed
• Conditions: Brain Activity Under Sedation
• Intervention / Treatment: Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, non-smoking male and female volunteers, ages 18-36 with normal body weight.
• American Society of Anesthesiologists (ASA) physical status I

Exclusion Criteria:

• History of head trauma
• Surgical aneurysm clips
• Cardiac pacemaker
• Prosthetic heart valve
• Neurostimulator
• Implanted pumps
• Cochlear implants
• Metal rods, plates
• Screws
• Intrauterine device
• Hearing aid
• Dentures (which might create NMR artifacts)
• Metal injury to eyes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Power in Alpha, Slow, and Delta Bands	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.	11 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (ESTIMATE): March 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 2005P001549; 5DP1OD003646 (NIH)