EEG Studies of Sevoflurane-Induced General Anesthesia

Ketamine

Brief Summary

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).

Intervention / Treatment

  • Sevoflurane (DRUG)
    Subjects will received sevoflurane for approximately 60 minutes.
  • Ketamine (DRUG)
    Subjects will received sevoflurane and ketamine for approximately 60 minutes.

Condition or Disease

  • Anesthesia

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 50 Years
    Enrollment: 12 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Basic Science

    Masking

    Clinical Trial Dates

    Start date: May 01, 2018 ACTUAL
    Primary Completion: Aug 01, 2018 ACTUAL
    Completion Date: Aug 01, 2018 ACTUAL
    Study First Posted: Apr 20, 2018 ACTUAL
    Results First Posted: Oct 24, 2019 ACTUAL
    Last Updated: Oct 01, 2019

    Sponsors / Collaborators

    Lead Sponsor: Massachusetts General Hospital
    Responsible Party: N/A

    Location

    Boston, Massachusetts, USA

    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.

    Participant Groups

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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.

    More Details

    NCT Number: NCT03503578
    Other IDs: 2014P000111
    Study URL: https://clinicaltrials.gov/study/NCT03503578
    Last updated: Sep 29, 2023