Trials / Unknown
UnknownNCT02873182
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Stanley Skinner · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Intervertebral Disc Degeneration
- Intervertebral Disc Displacement
- Spinal Curvatures
- Spinal Stenosis
- Spondylitis
- Spondylosis
- Osteoarthropathy, Primary Hypertrophic
- Spinal Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Autonomic nervous system monitoring | 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. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2016-08-19
- Last updated
- 2016-08-19
Source: ClinicalTrials.gov record NCT02873182. Inclusion in this directory is not an endorsement.