EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

NCT01543633 | Completed Results DMC

• 2 other identifiers: 2005P0015495DP1OD003646
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Brain Activity Under Sedation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Active Study Arm

EXPERIMENTAL

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

Interventions

Propofol DRUG

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).

Active Study Arm

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Emery N. Brown
• Organization: Neuroscience Statistics Research Laboratory, Massachusetts General Hospital

enb@neurostat.mit.edu

(617) 726-8786

Study Officials

• Emery N Brown, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emery N. Brown, M.D., Ph.D.

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 5, 2012
• Study Start: August 1, 2005
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (1)