EEG Studies of Sevoflurane-Induced General Anesthesia

NCT ID: NCT03503578

Last Updated: 2019-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-08-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EEG Dynamics

EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Subjects will received sevoflurane for approximately 60 minutes.

Ketamine

Intervention Type DRUG

Subjects will received sevoflurane and ketamine for approximately 60 minutes.

Interventions

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Sevoflurane

Subjects will received sevoflurane for approximately 60 minutes.

Intervention Type DRUG

Ketamine

Subjects will received sevoflurane and ketamine for approximately 60 minutes.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oluwaseun Johnson-Akeju, MD, MMSc

Associate Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2014P000111

Identifier Type: -

Identifier Source: org_study_id

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