A phase III sTudy evaluating the efficacy and safety of Trans-Esophageal Motor-evoked PoTential monitoring and the special electrode during aortic surgery

Phase 3

Suspended

Conditions: patients undergoing aortic surgery carrying the risk of ischemic spinal cord injury
D001018
ischemic spinal cord injury, aortic aneurysm, aortic dissection

Registration Number: JPRN-jRCT2042230116

Lead Sponsor: orihiko Shiiya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 100

Inclusion Criteria

1) patients scheduled to undergo aortic surgery carrying the risk of ischemic spinal cord injury and TC-MEP
2) patients aged 20 years or more on the day of giving informed consent
3) patients giving written informed consent to be enrolled in this trial

Exclusion Criteria

Patients meeting any of the following exclusion criteria on the day of enrollment are excluded.
1) patients undergoing aortic surgery within 24 hours after non-scheduled admission
2) patients having esophageal abnormality (severe compression or deviation causing esophageal obstruction by tumors or something else, esophageal varices with a arisk of bleeding, esophagus not locating in the normal anatomical position at theT4 level such as post-esophageal surgery, etc)
3) patients having head skin abnormality (resulting in difficulty of setting the transcranial stimuation elecrodes) at the stimulation points
4) patients having paralysis (such as hemiplegia or paraplegia) or neuromusclar diseases with severe
5) patients unable to walk without assistance due to prolonged bed rest or some other reasons
6) patients judged unsuitable by the investigators or subinvstigators

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic specificity for the neurological evaluation on awakening (within 18 hours after the conclusion of surgery) by the change in the amplitude of motor evoked potenstials at the conclusion of surgery

Secondary Outcome Measures