Trial Outcomes & Findings for EEG Studies of Sevoflurane-Induced General Anesthesia (NCT NCT03503578)
NCT ID: NCT03503578
Last Updated: 2019-10-24
Results Overview
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.
COMPLETED
PHASE2
12 participants
Approximately 60 minutes
2019-10-24
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EEG Studies of Sevoflurane-Induced General Anesthesia
Baseline characteristics by cohort
| Measure |
EEG Dynamics
n=12 Participants
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.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Approximately 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.
Outcome measures
| Measure |
EEG Dynamics
n=12 Participants
EEG data will be collected on patients receiving sevoflurane anesthesia.
|
|---|---|
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Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Alpha
|
10 Hz
|
|
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Theta
|
5 Hz
|
|
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Slow-Delta
|
1 Hz
|
Adverse Events
EEG Dynamics
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Oluwaseun Johnson-Akeju
Massachusetts General Hospital DACCPM
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place