Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery

Completed · Not applicable

Conditions studied: Ischemic Optic Neuropathy

In brief

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.

Key facts

Study ID

NCT02643615

Run by

Ohio State University

People needed

20

Starts

2014-09-01

Expected to finish

2016-03-01

Last updated by the study team

2017-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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