Clinical trial · Interventional
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
NCT02873182CI-TRIAL-00023568unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intervertebral Disc Degeneration | — | UNRESOLVED | — |
| Intervertebral Disc Displacement | — | UNRESOLVED | — |
| Osteoarthropathy, Primary Hypertrophic | — | UNRESOLVED | — |
| Spinal Curvatures | — | UNRESOLVED | — |
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spondylitis | — | UNRESOLVED | — |
| Spondylosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autonomic nervous system monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autonomic nervous system monitoring
- 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.
- interventionNames
- Device: Autonomic nervous system monitoring
Primary outcomes (1)
- measure
- Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
- timeFrame
- Duration of surgery
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.