Trial Outcomes & Findings for Anesthesia and Motor Evoked Potential (MEP) Recruitment (NCT NCT02199314)
NCT ID: NCT02199314
Last Updated: 2020-09-22
Results Overview
A series of 15 transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure. The series consisted of 3 runs of 5,6, 7, 8, and 9 pulse trains, each train separated by 30 seconds. The 3 runs were averaged to give and average value of TcMEP amplitude and area for the 5,6,7,8 and 9 pulse trains. The data were used to compute regression coefficients for area vs pulse length for the TIVA case and TIVA plus desflurane for each participant who completed the study..The final measure is the number of participants who had a MEP area ratios significantly different from 1 at all times and conditions; that is for TIVA alone and TIVA plus desflurane, at both time points.
COMPLETED
NA
30 participants
15 minutes
2020-09-22
Participant Flow
Participants were enrolled in Orthopaedics clinic during scheduled visit for pre-surgical planning. Parents/guardians were given the informed consent and participant were given assent documents. Anyone who agreed to participate at this time was considered enrolled for the purposes of the study. This number was 30.
There was no group assignment - each participant was to be his/her own control.
Participant milestones
| Measure |
MEPs Pre and Post Desflurane at 2 Time Points
Transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
MEPs Pre and Post Desflurane at 2 Time Points
Transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
10
|
Baseline Characteristics
30 participants initially enrolled. 12 were withdraw prior to start of study procedures. 6 withdrawn by participant and 6 by physician decision
Baseline characteristics by cohort
| Measure |
Desflurane MEP's
n=18 Participants
Transcranial motor evoked potentials are obtained under propofol/remifentanil TIVA anesthesia and the again under TIVA plus desflurane 3%, after desflurane has been on for at least 5 minutes, at two different time points; before incision and at the end of the procedure. Each patient is his/her own control
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|---|---|
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Age, Continuous
|
14 years
n=99 Participants • 30 participants initially enrolled. 12 were withdraw prior to start of study procedures. 6 withdrawn by participant and 6 by physician decision
|
|
Sex: Female, Male
Female
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14 Participants
n=99 Participants • Measure Analysis Population Description: 30 participants initially enrolled. 12 were withdraw prior to start of study procedures. 6 withdrawn by participant and 6 by physician decision
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants • Measure Analysis Population Description: 30 participants initially enrolled. 12 were withdraw prior to start of study procedures. 6 withdrawn by participant and 6 by physician decision
|
PRIMARY outcome
Timeframe: 15 minutesA series of 15 transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure. The series consisted of 3 runs of 5,6, 7, 8, and 9 pulse trains, each train separated by 30 seconds. The 3 runs were averaged to give and average value of TcMEP amplitude and area for the 5,6,7,8 and 9 pulse trains. The data were used to compute regression coefficients for area vs pulse length for the TIVA case and TIVA plus desflurane for each participant who completed the study..The final measure is the number of participants who had a MEP area ratios significantly different from 1 at all times and conditions; that is for TIVA alone and TIVA plus desflurane, at both time points.
Outcome measures
| Measure |
MEPs Pre and Post Desflurane at 2 Time Points
n=14 Participants
A series of 15 transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure. The series consisted of 3 runs of 5,6, 7, 8, and 9 pulse trains, each train separated by 30 seconds. The 3 runs were averaged to give and average value of TcMEP amplitude and area for the 5,6,7,8 and 9 pulse trains. The data were used to compute regression coefficients for area vs pulse length for the TIVA case and TIVA plus desflurane for each participant who completed the study..
|
|---|---|
|
Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
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2 Participants
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Adverse Events
Desflurane MEP's
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Desflurane MEP's
n=18 participants at risk
Transcranial motor evoked potentials are obtained under TIVA and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control
Desflurane
|
|---|---|
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Endocrine disorders
Enlarged thyroid
|
5.6%
1/18 • Number of events 1
|
Additional Information
John J McAuliffe, MD
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place