Assessment and finalization of a stimulation electrode for trans-esophageal motor-evoked potential

JRCT ID: jRCTs042210032

Registered date:14/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Aortic aneurysm, aortic dissection, aortic injury, etc.
• Date of first enrollment: 17/09/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): In addition to transcranial motor evoked potentials, transesophageal motor evoked potentials are monitored during aortic surgery using an equipment for neurophysiological measurements.

Outcome(s)

• Primary Outcome: Variation of the amplitude of motor evoked potentials before and after insertion of a transesophageal echo probe

Secondary Outcome

Ease of insertion (subjective 5-point scale)
Ratio of the amplitude of motor evoked potentials obtained by 150mA and 200mA stimulation
Diagnostic accuracy of neurological poutcomes by the changes in motor evoked potentials during and at the conclusion of surgery
Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients undergoing elective aortic surgery with a risk of spinal cord ischemic injury who are to be monitored for transcranial motor evoked potentials in the ordinary course of medical treatment (aortic surgery mainly in the descending or thoracoabdominal aorta for aortic aneurysms, aortic dissection, aortic injury, etc.)

Exclude criteria

Patients undergoing emergent or urgent aortic surgery (within 24 hours of admission)
Patients with abnormalities of the esophagus (tumors, varices, post-esophageal surgery, whigh degree compression deviation causing obstruction)
Patients who are judged inappropriate by the principal investigator (or sub-investigator).

Related Information

• Primary Sponsor: Shiiya Norihiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development