EEG Studies of Sevoflurane-Induced General Anesthesia

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03503578
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Sevoflurane; Drug: Ketamine	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Electroencephalogram Studies of Induction and Recovery From Sevoflurane-Induced General Anesthesia
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EEG Dynamics EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.	Drug: Sevoflurane; Subjects will received sevoflurane for approximately 60 minutes.; Drug: Ketamine; Subjects will received sevoflurane and ketamine for approximately 60 minutes.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 24, 2018

More Information

Publications

None provided.

• Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Associate Professor of Anaesthesia, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03503578
• Other Study ID Numbers: 2014P000111
• First Posted: Apr 20, 2018
• Last Update Posted: Oct 24, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Ketamine; Sevoflurane

Study Results

Participant Flow

Arm/Group Title	EEG Dynamics
Arm/Group Description	EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together. Sevoflurane: Subjects will received sevoflurane for approximately 60 minutes. Ketamine: Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	EEG Dynamics
Arm/Group Description	EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together. Sevoflurane: Subjects will received sevoflurane for approximately 60 minutes. Ketamine: Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (4.7)
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 8.3%
Not Hispanic or Latino	11 91.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 25%
White	8 66.7%
More than one race	1 8.3%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Description	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.
Time Frame	Approximately 60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Dynamics
Arm/Group Description	EEG data will be collected on patients receiving sevoflurane anesthesia.
Measure Participants	12
Alpha	10
Theta	5
Slow-Delta	1

Adverse Events

Time Frame	From initiation of anesthesia during the first study visit to completion of the second study visit. Study visits typically occurred less than 1 week apart.
Adverse Event Reporting Description	Adverse events and other events were determined by regular investigator assessment and self-reporting.
Arm/Group Title	EEG Dynamics
Arm/Group Description	EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together. Sevoflurane: Subjects will received sevoflurane for approximately 60 minutes. Ketamine: Subjects will received sevoflurane and ketamine for approximately 60 minutes.
All Cause Mortality
	EEG Dynamics
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	EEG Dynamics
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	EEG Dynamics
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.