EEG Studies of Sevoflurane-Induced General Anesthesia

Phase 2

Completed

• Conditions: Anesthesia
• Interventions: Drug: Sevoflurane; Drug: Ketamine

• Registration Number: NCT03503578
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-20
• Study Start: 2018-05-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Results First Submitted: 2019-08-02
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Results First Posted: 2019-10-24
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEG Dynamics	Sevoflurane	EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.
EEG Dynamics	Ketamine	EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.

Primary Outcome Measures

Name	Time	Method
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States