Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis, Osteoarthropathy, Primary Hypertrophic, Spinal Neoplasms
Conditions
Keywords
Intraoperative monitoring, Intraoperative neuromonitoring, Autonomic nervous system, Spine surgery, Pelvic surgery, Sexual function, Bowel function, Bladder function
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.
Interventions
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.
Sponsors
Stanley Skinner
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Contacts
Primary ContactAnna Lintelmann, MPH
Backup ContactAmy Schrecengost, BS
Outcome results
None listed