N/A
N=20
A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia
Evoked Potentials, Visual
Bottom Line
View on ClinicalTrials.gov: NCT02563028 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Presence of VEPs — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SightSaver Visual Stimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Presence of VEPs |
18 | — |
| SECONDARY Number of Participants With Change in VEP Signal Strength |
18 | — |
| SECONDARY Correlation of Change in VEPs With Identifiable Intraoperative Event |
18 | — |
| SECONDARY Number of Participants With Intolerance to the SightSaver Visual Stimulator |
1 | — |
Summary
Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness. Known risk factors include low blood count (anemia) and long surgical times in the prone position under general anesthesia. While blindness is a rare outcome of this surgery, it is devastating and incompletely prevented by controlling known risk factors. Thus, improved monitoring and detection of visual injury during surgery is necessary. The purpose of this study is to determine whether a novel, non-invasive monitoring device can reliably record visual responses during spine surgery. The first phase of this study is completed and involved patients undergoing microdiscectomy surgery. The second phase of this study involves patients undergoing single-level lumbar spine decompression/fusion surgery.
Eligibility Criteria
Inclusion Criteria
- Any patient presenting for single-level microdiscectomy (first phase only)
- Any patient presenting for single-level lumbar spine decompression/fusion (second phase only)
- Any patient suitable for total intravenous anesthesia (TIVA)
- Age >18
Exclusion Criteria
- Neurologic or demyelinating disease expected to be associated with impaired VEPs
- Eye disease, including blindness, glaucoma, macular degeneration, diabetic retinopathy, or conditions expected to be associated with impaired VEPs
- Patients with a known history of seizures
Data sourced from ClinicalTrials.gov (NCT02563028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.