EEG Studies of Sevoflurane-Induced General Anesthesia

October 1, 2019 updated by: Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Electroencephalogram Studies of Induction and Recovery From Sevoflurane-Induced General Anesthesia

The investigators are performing this research study to find out how and where the anesthetic drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness). The investigators will study the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During this research study, participants will receive sevoflurane, and sevoflurane and ketamine together, at a high enough dose to induce general anesthesia (make study participants "fall asleep"). During one visit participants will receive only sevoflurane; during another visit participants will be given both sevoflurane and ketamine together. The investigators will record EEG the entire time. The investigators will also ask some questions related to pain and cognitive function.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 18 and 50
  • Normal body weight and habitus, BMI ≤ 30
  • Non-smoker
  • American Society of Anesthesiologists (ASA) physical status classification P1

Exclusion Criteria:

  • Chronic health conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EEG Dynamics
EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.
Drug: Sevoflurane
Subjects will received sevoflurane for approximately 60 minutes.
Drug: Ketamine
Subjects will received sevoflurane and ketamine for approximately 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Time Frame: Approximately 60 minutes
Changes in power from baseline at various EEG spectral frequencies were assessed at sevoflurane-induced loss of responsiveness. EEGs of 12 patients were analyzed to determine changes in various EEG spectral frequencies (alpha, theta, delta, etc.) from baseline. The outcome measure reflects the associated frequency (Hz) at which changes were found under sevoflurane-induced general anesthesia. These frequency values are a representation of the findings for all 12 participants.
Approximately 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P000111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia

Clinical Trials on Sevoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe