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EEG Studies of Sevoflurane-Induced General Anesthesia

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03503578
Enrollment
12
Registered
2018-04-20
Start date
2018-05-01
Completion date
2018-08-01
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGSevoflurane

Subjects will received sevoflurane for approximately 60 minutes.

DRUGKetamine

Subjects will received sevoflurane and ketamine for approximately 60 minutes.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General AnesthesiaApproximately 60 minutesChanges 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
EEG Dynamics
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.
12
Total12

Baseline characteristics

CharacteristicEEG Dynamics
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
Age, Continuous25 years
STANDARD_DEVIATION 4.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
8 Participants
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

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.

Time frame: Approximately 60 minutes

ArmMeasureGroupValue (NUMBER)
EEG DynamicsFrequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General AnesthesiaAlpha10 Hz
EEG DynamicsFrequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General AnesthesiaTheta5 Hz
EEG DynamicsFrequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General AnesthesiaSlow-Delta1 Hz

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026