Working… Menu

EEG Studies of Ketamine General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03553758
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : January 8, 2019
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Brief Summary:
We are doing this research study to find out how and where ketamine acts in the brain. Ketamine is an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by putting you in an unconscious state). We will look at the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG).

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Ketamine Phase 2 Phase 3

Detailed Description:
In this trial, participants will be given ketamine at a high enough dosage to induce general anesthesia. EEG recording will be conducted during this time. Cognitive assessments, computer tasks and pain monitoring will be administered.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Electroencephalogram Studies of Induction and Recovery From Ketamine-Induced General Anesthesia
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine EEG Dynamics
EEG recordings will be obtained from 15 subjects undergoing ketamine general anesthesia.
Drug: Ketamine
Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximatel 60 minutes.

Primary Outcome Measures :
  1. EEG power at ketamine-included loss of responsiveness [ Time Frame: Approximately 60 minutes ]
    EEG power examined at ketamine-included loss of responsiveness

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Between the ages of 18 to 45
  • Normal body weight and habitus, BMI less than or equal to 30
  • Non-smoker
  • American Society of Anesthesiologists (ASA) physical status classification P1

Exclusion Criteria:

  • Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
  • Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
  • Hepatic: hepatitis, jaundice, ascites
  • Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
  • Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
  • Endocrine: diabetes, thyroid disease
  • Renal: acute or chronic severe renal insufficiency
  • Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
  • Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
  • Psychiatric: history or treatment for an active psychiatric problem, depression
  • Reproductive: pregnancy, breast-feeding
  • Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
  • Allergies: labetalol, ondansetron, glycopyrrolate, ketamine, midazolam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03553758

Layout table for location contacts
Contact: Oluwaseun Johnson-Akeju, M.D., M.M.Sc. 617-724-7200

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.    617-724-7200   
Principal Investigator: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.         
Sponsors and Collaborators
Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Associate Professor of Anaesthesia, Massachusetts General Hospital Identifier: NCT03553758     History of Changes
Other Study ID Numbers: 2018P000417
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Layout table for additional information
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.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action