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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2017
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Test the hypothesis to recruit larger motor responses to transcranial stimulation.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Desflurane


Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

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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