Anesthesia and Motor Evoked Potential (MEP) Recruitment

Not Applicable

Completed

• Conditions: Idiopathic Scoliosis
• Interventions: Drug: Desflurane

• Registration Number: NCT02199314
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Primary Completion: 2016-04
• Study Completion: 2017-03
• Status Verified: 2017-11
• Results First Submitted: 2020-08-31
• Results First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Results First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
desflurane MEP's	Desflurane	Transcranial motor evoked potentials are obtained under total intravenous anesthesia (TIVA) and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States