Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Post-operative visual loss (POVL) following non-ocular surgical procedures is an infrequent
but severe complication. Little is understood about this complication, but most cases seem to
result from loss of blood flow to the optic nerve. This is a pilot, single center,
prospective, randomized, two-arm study involving 20 subjects at The Ohio State University
Wexner Medical Center who are scheduled to undergo spine surgery that requires prone position
and at least two hours of general anesthesia or total intravenous anesthesia (TIVA) and
intraoperative neurophysiological monitoring. Patients will be randomized to either general
anesthesia or TIVA, and wear the SightSaver device to monitor visual evoked potentials (VEPs)
during surgery in order to detect possible changes in optic nerve function that may lead to
POVL. We hypothesize that this new, flexible, disposable device will yield better results and
more patient satisfaction than devices currently used for visual monitoring during prone
spine surgeries.