At a glance
ClinicalIndex Comparison Record- ✓Age >18 years
- ✓ASA status I-IV
- ✓Scheduled for elective spinal prone procedure under general anesthesia or TIVA with intraoperative neurophysiological monitoring
- ✓Expected surgery duration ≥2 hours
- ✕Prisoner status
- ✕Pregnant or lactating women
- ✕History of contact allergies to foam and/or plastic devices
- ✕Unstable cardiovascular, pulmonary, renal, hepatic, neurologic, hematologic, or endocrine abnormalities (seizures, hyperthyroidism, unstable diabetes)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study to Determine the Efficacy and Safety of Detecting Subtle Visual Changes During Visual Evoked Potential (VEP) Monitoring Using SightSaver ™ Flash Visual Evoked Potential Stimulator in Spine Prone Surgery
In Brief
A clinical study evaluating VEP under TIVA, VEP under balanced anesth., and 2 other interventions for Ischemic Optic Neuropathy. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.