Clinical trial NCT02873182: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
timeFrame: Duration of surgery
Secondary outcomes:
measure: Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.
timeFrame: Duration of Surgery
measure: The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.
timeFrame: Duration of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Allina Health
name: Nilanjana Banerji, MS, PhD
role: STUDY_DIRECTOR
affiliation: Allina Health
name: Stanley Skinner, MD
role: PRINCIPAL_INVESTIGATOR
References: