EEG Studies of Sevoflurane-Induced General Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503578
• Other study ID #: 2014P000111
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia	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.	Approximately 60 minutes