Idiopathic Scoliosis Clinical Trial
Official title:
The Effect of Anesthesia on the Recruitment of Motor Evoked Potentials Using an Increased Number of Pulses
NCT number | NCT02199314 |
Other study ID # | 2012-1065 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | March 2017 |
Verified date | November 2017 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Test the hypothesis to recruit larger motor responses to transcranial stimulation.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2017 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 15 minutes |
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