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NCT02643615 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02643615 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 20 participants.
The verdict
NCT02643615, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Propofol
- DRUG Desflurane
- DEVICE VEP under TIVA
- DEVICE VEP under balanced anesth.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02643615
The ClinicalTrials.gov registry entry for NCT02643615 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Propofol is the first listed.
NCT02643615 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02643615 about?
NCT02643615 is a clinical study titled "Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery". 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-ar...
What is the current status of trial NCT02643615?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2014-09. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02643615?
The interventions under investigation include: Propofol (DRUG), Desflurane (DRUG), VEP under TIVA (DEVICE), VEP under balanced anesth. (DEVICE).
Who is sponsoring clinical trial NCT02643615?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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