Anesthesia and Motor Evoked Potential (… | Clinical Trial

Key information

Conditions

Idiopathic Scoliosis

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

Other names: Suprane

Primary outcomes

Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

The Effect of Anesthesia on the Recruitment of Motor Evoked Potentials Using an Increased Number of Pulses

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Jul 24, 2014
Registry last updated: Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed