Idiopathic Scoliosis
Conditions
Keywords
intra, operative, neurophysiologic, monitoring, transcranial, motor, evoked, potential, anesthesia, pulses
Brief summary
Test the hypothesis to recruit larger motor responses to transcranial stimulation.
Detailed description
The study is designed to test the hypothesis that it is possible to recruit larger motor responses to transcranial stimulation by increasing the number of stimulating pulses under both baseline conditions and conditions of increased anesthetic suppression of the motor responses.
Interventions
DRUGDesflurane
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 12 through 17 years * Diagnosis of idiopathic scoliosis * Scheduled for posterior spinal fusion with neurophysiological monitoring * No known allergies to propofol or remifentanil * No contraindication to total intravenous anesthesia * No contraindications to the administration of volatile agents
Exclusion criteria
* Failure to consent or assent to study * Diagnosis other than idiopathic scoliosis * Poorly controlled seizures or the presence of a cochlear implant * Patient history or family history of malignant hypothermia or mitochondrial myopathies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane | 15 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
There was no group assignment - each participant was to be his/her own control.
Participants by arm
| Arm | Count |
|---|---|
| Desflurane MEP's 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 | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 10 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Desflurane MEP's |
|---|---|
| Age, Continuous | 14 years |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
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.
Time frame: 15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MEPs Pre and Post Desflurane at 2 Time Points | Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane | 2 Participants |