EEG Studies of Sevoflurane-Induced General Anesthesia

• 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: Massachusetts General Hospital
• Information provided by (Responsible Party): Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Tracking Information

• First Submitted Date: April 5, 2018
• First Posted Date: April 20, 2018
• Results First Submitted Date: August 2, 2019
• Results First Posted Date: October 24, 2019
• Last Update Posted Date: October 24, 2019
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EEG Studies of Sevoflurane-Induced General Anesthesia
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Anesthesia

Intervention

• Drug: Sevoflurane
  Subjects will received sevoflurane for approximately 60 minutes.
• Drug: Ketamine
  Subjects will received sevoflurane and ketamine for approximately 60 minutes.

Study Arms

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2018): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 1, 2018
• Actual Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03503578
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Massachusetts General Hospital
• Verification Date: October 2019