Spots Global Cancer Trial Database for Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

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Trial Identification

Brief Title: Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

Official Title: Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

Study ID: NCT02873182

Conditions

Intervertebral Disc Degeneration

Intervertebral Disc Displacement

Osteoarthropathy, Primary Hypertrophic

Spinal Neoplasms

Interventions

Autonomic nervous system monitoring

Study Description

Brief Summary: 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.

Detailed Description: 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.