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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis, Osteoarthropathy, Primary Hypertrophic, Spinal Neoplasms

Intervention / Treatment
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* Device: Autonomic nervous system monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be ≥ 18 years of age Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital Patients must be capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed. Exclusion Criteria: Patients ≥ 70 years of age Patients with obvious groin infection and/or herniation Patients with ongoing psychiatric concerns

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autonomic nervous system monitoring<br>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 all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. | Device: Autonomic nervous system monitoring<br>* Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions. | Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded. | Duration of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings. | Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency in response to IOMN (intraoperative neuromonitoring) stimulations and recordings, will be recorded. | Duration of Surgery | 
| The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations. |  | Duration of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative monitoring, Intraoperative neuromonitoring, Autonomic nervous system, Spine surgery, Pelvic surgery, Sexual function, Bowel function, Bladder function