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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
Stanley Skinner
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must be ≥ 18 years of age
  2. Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
  3. 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:

  1. Patients ≥ 70 years of age
  2. Patients with obvious groin infection and/or herniation
  3. 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

    First Posted
    August 10, 2016
    Last Updated
    August 16, 2016
    Sponsor
    Stanley Skinner
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    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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