Anesthesia and Motor Evoked Potential (MEP) Recruitment

NCT02199314 | Completed Results

• 1 other identifier: 2012-1065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Scoliosis

Keywords

intra; operative; neurophysiologic; monitoring; transcranial; motor; evoked; potential; anesthesia; pulses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

desflurane MEP's

EXPERIMENTAL

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

Drug: Desflurane

Interventions

Desflurane DRUG

Also known as: Suprane

desflurane MEP's

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Desflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: John J McAuliffe, MD
• Organization: Cincinnati Children's Hospital Medical Center

john.mcauliffe@cchmc.org

1513-636-4408

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: July 24, 2014
• Study Start: March 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)