Spinal Stenosis Clinical Trial
Official title:
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.
This is a safety and efficacy trial to assess autonomic neural function monitoring during
spinal and/or pelvic surgery.
During standard intraoperative neuromonitoring, additional smooth muscle free-running and
stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female
genitalia from individual patients. Throughout the duration of the spinal surgery, the
neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running
(continuous) and stimulated EMG will be recorded.
EMG data and additional demographics and clinical data (e.g. operative time, adverse events)
will be collected for each patient. The success rates of 1) credible and safe EMG recording
and 2) positive EMG responses to each stimulation method will be calculated.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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