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Clinical Trials/NCT03503578
NCT03503578
Completed
Phase 2

Electroencephalogram Studies of Induction and Recovery From Sevoflurane-Induced General Anesthesia

Massachusetts General Hospital1 site in 1 country12 target enrollmentMay 1, 2018

Overview

Phase
Phase 2
Intervention
Ketamine
Conditions
Anesthesia
Sponsor
Massachusetts General Hospital
Enrollment
12
Locations
1
Primary Endpoint
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
August 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Oluwaseun Johnson-Akeju, MD, MMSc

Associate Professor of Anaesthesia

Massachusetts General Hospital

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

Arms & Interventions

EEG Dynamics

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

Intervention: Ketamine

EEG Dynamics

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

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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.

Study Sites (1)

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