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

Not Applicable

• Conditions: Spondylitis; Spondylosis; Spinal Neoplasms; Osteoarthropathy, Primary Hypertrophic; Spinal Curvatures; Spinal Stenosis; Intervertebral Disc Degeneration; Intervertebral Disc Displacement
• Interventions: Device: Autonomic nervous system monitoring

• Registration Number: NCT02873182
• Lead Sponsor: Stanley Skinner

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Posted: 2016-08-19
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autonomic nervous system monitoring	Autonomic nervous system monitoring	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.

Primary Outcome Measures

Name	Time	Method
Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.	Duration of surgery	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.

Secondary Outcome Measures

Name	Time	Method
Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.	Duration of Surgery	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.
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