EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

Not Applicable

Completed

• Conditions: Brain Activity Under Sedation
• Interventions: Drug: Propofol

• Registration Number: NCT01543633
• Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Results First Submitted: 2021-09-29
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-13
• Last Update Submitted: 2021-12-13
• Results First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Study Arm	Propofol	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.

Primary Outcome Measures

Name	Time	Method
EEG Power in Alpha, Slow, and Delta Bands	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States