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

Stanley Skinner

Status: Unknown

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

Treatments: Device: Autonomic nervous system monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02873182

NSSS-1601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be ≥ 18 years of age
2. Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
3. 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

1. Patients ≥ 70 years of age
2. Patients with obvious groin infection and/or herniation
3. Patients with ongoing psychiatric concerns

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Autonomic nervous system monitoring

Experimental group

Description:

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.

Treatment:

Device: Autonomic nervous system monitoring