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EEG Studies of Sevoflurane-Induced General Anesthesia

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ClinicalTrials.gov Identifier: NCT03503578
Recruitment Status : Completed
First Posted : April 20, 2018
Results First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE April 20, 2018
Results First Submitted Date  ICMJE August 2, 2019
Results First Posted Date  ICMJE October 24, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
Change in multitaper spectral estimates of EEG power during sevoflurane-induced general anesthesia. [ Time Frame: Approximately 60 minutes ]
Change from baseline in multitaper spectral estimates of EEG power at sevoflurane-induced loss of responsiveness.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EEG Studies of Sevoflurane-Induced General Anesthesia
Official Title  ICMJE Electroencephalogram Studies of Induction and Recovery From Sevoflurane-Induced General Anesthesia
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Sevoflurane
    Subjects will received sevoflurane for approximately 60 minutes.
  • Drug: Ketamine
    Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Study Arms  ICMJE Experimental: EEG Dynamics
EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.
Interventions:
  • Drug: Sevoflurane
  • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03503578
Other Study ID Numbers  ICMJE 2014P000111
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP