Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
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|ClinicalTrials.gov Identifier: NCT02873182|
Recruitment Status : Unknown
Verified August 2016 by Stanley Skinner, Allina Health System.
Recruitment status was: Not yet recruiting
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intervertebral Disc Degeneration Intervertebral Disc Displacement Spinal Curvatures Spinal Stenosis Spondylitis Spondylosis Osteoarthropathy, Primary Hypertrophic Spinal Neoplasms||Device: Autonomic nervous system monitoring||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: 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.
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.
- Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions. [ Time Frame: 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.
- Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings. [ Time Frame: 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. [ Time Frame: Duration of surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873182
|Contact: Anna Lintelmann, MPH||612/863-5413||Anna.Lintelmann@allina.com|
|Contact: Amy Schrecengost, BS||612/863-6562||Amy.Schrecengost@allina.com|
|Study Director:||Nilanjana Banerji, MS, PhD||Allina Health|
|Principal Investigator:||Stanley Skinner, MD||Allina Health|