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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Stanley Skinner

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Allina Health System

Dates:
Date Received: August 10, 2016
Date Started: August 2016
Date Completion: August 2018
Last Updated: August 16, 2016
Last Verified: August 2016