Anesthesia and Motor Evoked Potential (MEP) Recruitment

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT02199314
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 48
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Scoliosis	Drug: Desflurane	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of Anesthesia on the Recruitment of Motor Evoked Potentials Using an Increased Number of Pulses
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: desflurane MEP's 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; Other Names: Suprane

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02199314
• Other Study ID Numbers: 2012-1065
• First Posted: Jul 24, 2014
• Last Update Posted: Sep 22, 2020
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Children's Hospital Medical Center, Cincinnati: intra; operative; neurophysiologic; monitoring; transcranial; motor; evoked; potential; anesthesia; pulses
• Additional relevant MeSH terms: Scoliosis; Desflurane

Study Results

Participant Flow

Recruitment Details	Participants were enrolled in Orthopaedics clinic during scheduled visit for pre-surgical planning. Parents/guardians were given the informed consent and participant were given assent documents. Anyone who agreed to participate at this time was considered enrolled for the purposes of the study. This number was 30.
Pre-assignment Detail	There was no group assignment - each participant was to be his/her own control.

Arm/Group Title	MEPs Pre and Post Desflurane at 2 Time Points
Arm/Group Description	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
Period Title: Overall Study
STARTED	30
COMPLETED	14
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Desflurane MEP's
Arm/Group Description	Transcranial motor evoked potentials are obtained under propofol/remifentanil TIVA anesthesia and the again under TIVA plus desflurane 3%, after desflurane has been on for at least 5 minutes, at two different time points; before incision and at the end of the procedure. Each patient is his/her own control
Overall Participants	18
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	14
Sex: Female, Male (Count of Participants)
Female	14 77.8%
Male	4 22.2%

Outcome Measures

1. Primary Outcome

Title	Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
Description	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.
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MEPs Pre and Post Desflurane at 2 Time Points
Arm/Group Description	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..
Measure Participants	14
Count of Participants [Participants]	2 11.1%

Adverse Events

Arm/Group Title	Desflurane MEP's
Arm/Group Description	Transcranial motor evoked potentials are obtained under TIVA and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control Desflurane
All Cause Mortality
	Desflurane MEP's
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	Desflurane MEP's
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Desflurane MEP's
	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)
Endocrine disorders
Enlarged thyroid	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.