Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
Primary Purpose
Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autonomic nervous system monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Intervertebral Disc Degeneration focused on measuring Intraoperative monitoring, Intraoperative neuromonitoring, Autonomic nervous system, Spine surgery, Pelvic surgery, Sexual function, Bowel function, Bladder function
Eligibility Criteria
Inclusion Criteria:
- Patients must be ≥ 18 years of age
- Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
- 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:
- Patients ≥ 70 years of age
- Patients with obvious groin infection and/or herniation
- Patients with ongoing psychiatric concerns
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autonomic nervous system monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02873182
Brief Title
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
Official Title
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stanley Skinner
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis, Osteoarthropathy, Primary Hypertrophic, Spinal Neoplasms
Keywords
Intraoperative monitoring, Intraoperative neuromonitoring, Autonomic nervous system, Spine surgery, Pelvic surgery, Sexual function, Bowel function, Bladder function
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autonomic nervous system monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Autonomic nervous system monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
Description
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.
Time Frame
Duration of surgery
Secondary Outcome Measure Information:
Title
Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.
Description
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.
Time Frame
Duration of Surgery
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be ≥ 18 years of age
Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
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:
Patients ≥ 70 years of age
Patients with obvious groin infection and/or herniation
Patients with ongoing psychiatric concerns
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Lintelmann, MPH
Phone
612/863-5413
Email
Anna.Lintelmann@allina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Schrecengost, BS
Phone
612/863-6562
Email
Amy.Schrecengost@allina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilanjana Banerji, MS, PhD
Organizational Affiliation
Allina Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stanley Skinner, MD
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
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