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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autonomic nervous system monitoring | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic nervous system monitoring | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Lintelmann, MPH | Contact | 612/863-5413 | Anna.Lintelmann@allina.com | |
| Amy Schrecengost, BS | Contact | 612/863-6562 | Amy.Schrecengost@allina.com |
| Name | Affiliation | Role |
|---|---|---|
| Nilanjana Banerji, MS, PhD | Allina Health | Study Director |
| Stanley Skinner, MD | Allina Health | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2021 | |
| Reset | Jun 14, 2021 | |
| Release | Jul 5, 2022 |
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|
| 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 |
| Reset | Jul 26, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2021 | Jun 14, 2021 | |||
| Jul 5, 2022 | Jul 26, 2022 |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| D013121 | Spinal Curvatures |
| D013130 | Spinal Stenosis |
| D013166 | Spondylitis |
| D055009 | Spondylosis |
| D010004 | Osteoarthropathy, Primary Hypertrophic |
| D013125 | Spinal Neoplasms |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D007592 | Joint Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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