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: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Anesthetics; Desflurane; Isoflurane; Propofol

Criteria

Inclusion Criteria:

• Male or Female older than 18 years of age

• American Society of Anesthesiologists (ASA) status of I to IV and scheduled to undergo elective spinal prone position procedures under general anesthesia or TIVA only with intraoperative neurophysiological monitoring with an expected duration of surgery to be at least 2 hours

• If female, have been surgically sterilized or are postmenopausal; if of child-bearing potential, must have a negative serum pregnancy test the day of surgery

• Ability and willingness to sign informed consent

• Literate in the English language

Exclusion Criteria:

• Prisoner status

• Women who are pregnant or lactating/breast feeding

• Patients with a history of contact allergies to foam and/or plastic devices

• Any condition, which, in the opinion of the investigator, would make the subject ineligible for participation in the study, such as a history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable Diabetes type I/II)