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A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia

A Novel Method for Capturing the Visual Evoked Potential (VEP) During Single-Level Lumbar Spine Decompression/Fusion Under Total Intravenous Anesthesia (TIVA)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02563028
Acronym
VEP
Enrollment
20
Registered
2015-09-29
Start date
2015-10-31
Completion date
2016-10-31
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evoked Potentials, Visual

Keywords

Visual Evoked Potentials, Microdiscectomy, SightSaver

Brief summary

Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness. Known risk factors include low blood count (anemia) and long surgical times in the prone position under general anesthesia. While blindness is a rare outcome of this surgery, it is devastating and incompletely prevented by controlling known risk factors. Thus, improved monitoring and detection of visual injury during surgery is necessary. The purpose of this study is to determine whether a novel, non-invasive monitoring device can reliably record visual responses during spine surgery. The first phase of this study is completed and involved patients undergoing microdiscectomy surgery. The second phase of this study involves patients undergoing single-level lumbar spine decompression/fusion surgery.

Detailed description

Spine surgery is associated with a variety of post-operative visual complications, ranging from mild, transient deficits in acuity to full visual loss. Known risk factors for visual loss include anemia, hypotension, and long surgical times in the prone position under general anesthesia. Despite recognition and control of risk factors, the prevalence of visual loss after prone spine surgery is estimated at approximately 0.1-1% . The pathophysiology of visual loss most often reflects posterior ischemic optic neuropathy, but anterior ischemic optic neuropathy and posterior reversible encephalopathy syndrome have also been described. These reports suggest that the entire pathway from retina to visual cortex is vulnerable to injuries causing post-operative visual deficits. The potential for severe injury during spine surgery mandates improved detection of evolving optic tract injury during prone spine surgery. Theoretically, the flash visual evoked potential (VEP) represents a useful intraoperative tool to monitor global visual system function. However, its application to spine surgery has been limited due to challenges in acquiring and interpreting signals intraoperatively. Several devices for intraoperative VEP-recording have been described . However, most of these have been trialed with patients in the supine or beach chair position, undergoing neurosurgical procedures. Goggle or eyepatch-designed devices have the potential to move during surgery, changing the relationship between the goggle and globe. The goggle itself may potentially compress the globe, producing inconsistent illumination to the retina or causing mechanical injury. These are particular liabilities during changes in position from supine to prone, as is required for many spine surgeries. Additionally, VEPs are extremely variable and exquisitely sensitive to anesthetics- particularly inhaled agents. Consistent with this, intravenous (rather than inhaled) agents have been associated with successful intraoperative VEP monitoring patients, particularly in patients without baseline visual impairment. Nonetheless, there are multiple reports in the literature showing poor correlation/prediction of postoperative visual status by intraoperative VEP measurements. A novel technology for capturing VEPs has recently been developed and may address several of the liabilities described above. The device is constructed from soft foam padding in a ski mask design, which we hypothesize may add a measure of protection to the eyes compared to traditional VEP goggles or patches. This design may also provide stability during changes in patient positioning from supine to prone. The front of the mask consists of an opaque circuit board with six bright light emitting diodes positioned in front of each eye, allowing illumination of the retina through closed, protected eyes. Opaque foam separates right and left sides of the mask, allowing each eye to be stimulated individually. To date, the mask has not been tested for sensitivity to elicit and record VEPs in patients under anesthesia. In this pilot study, we tested the feasibility of using the mask during prone spine surgery. Specifically, we asked if VEPs can be detected throughout spine surgeries of varying complexity and duration, whether the signals change with changes in patient positioning and anesthetic conditions, and whether the mask was associated with any adverse effects. Here we show that intraoperative VEPs can be recorded throughout spine surgery using this device. We also describe effects of several anesthetic agents on VEP stability, and ask if there is any qualitative relationship between changes in VEPs and SSEPs recorded simultaneously.

Interventions

DEVICESightSaver Visual Stimulator

Evoked response photic stimulator

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Any patient presenting for single-level microdiscectomy (first phase only) * Any patient presenting for single-level lumbar spine decompression/fusion (second phase only) * Any patient suitable for total intravenous anesthesia (TIVA) * Age \>18

Exclusion criteria

* Neurologic or demyelinating disease expected to be associated with impaired VEPs * Eye disease, including blindness, glaucoma, macular degeneration, diabetic retinopathy, or conditions expected to be associated with impaired VEPs * Patients with a known history of seizures

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Presence of VEPsDuration of surgery (approximately 3 hours)The primary outcome will be the presence of VEPs during spine surgery. This outcome will be measured in realtime, intraoperatively. Outcome measure: Visual evoked potential morphology, varying in amplitude (µV) and latency.

Secondary

MeasureTime frameDescription
Number of Participants With Change in VEP Signal StrengthDuration of surgery (approximately 3 hours)Number of participants with change in VEP signal strength. This outcome will be measured in realtime, intraoperatively.
Correlation of Change in VEPs With Identifiable Intraoperative EventDuration of surgery (approximately 3 hours)Whether changes in VEPs vary with any identifiable intraoperative change in patient condition (including hypotension, hypertension, tachycardia, bradycardia, arrhythmias, oxygen saturation, CO2 level, hypothermia and hyperthermia), surgical event (including sudden or ongoing hemorrhage, neurological injury), or anesthetic change (including increasing/decreasing doses of anesthetics, depth of anesthesia and use of vasoactive drugs). This outcome will be measured in realtime, intraoperatively. Number of participants with change in VEPs associated with increases or decreases of isoflurane and nitrous oxide are reported.
Number of Participants With Intolerance to the SightSaver Visual StimulatorPostoperatively, after recovery from anesthesia (approximately 3 hours after surgery)Whether the SightSaverTM Visual Stimulator is well tolerated by patients. This outcome will be assessed in the PACU will comprise a clinical exam of the periorbital structures and a patient questionnaire

Countries

United States

Participant flow

Participants by arm

ArmCount
Evoked Response Photic Stimulator
Arms Assigned Interventions Experimental: SightSaver Visual Stimulator A SightSaver Visual Stimulator mask will be applied during surgery. Baseline VEPs will be recorded prior to prone positioning. At the end of surgery, after supine positioning, the SightSaver Visual Stimulator mask will be removed and discarded. Device: SightSaver Visual Stimulator Evoked response photic stimulator
20
Total20

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLack of equipment1
Overall StudyUnable to elicit VEP post induction1

Baseline characteristics

CharacteristicEvoked Response Photic Stimulator
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
Age, Continuous54 Years
STANDARD_DEVIATION 16
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
16 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
1 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

Number of Participants With Presence of VEPs

The primary outcome will be the presence of VEPs during spine surgery. This outcome will be measured in realtime, intraoperatively. Outcome measure: Visual evoked potential morphology, varying in amplitude (µV) and latency.

Time frame: Duration of surgery (approximately 3 hours)

Population: Patients \>18 years old who underwent posterior spine surgery with general anesthesia were enrolled. Surgeries were microdiscectomy or instrumented fusion, irrespective of surgical type or patient position (supine or prone).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SightSaver Visual StimulatorNumber of Participants With Presence of VEPs18 Participants
Secondary

Correlation of Change in VEPs With Identifiable Intraoperative Event

Whether changes in VEPs vary with any identifiable intraoperative change in patient condition (including hypotension, hypertension, tachycardia, bradycardia, arrhythmias, oxygen saturation, CO2 level, hypothermia and hyperthermia), surgical event (including sudden or ongoing hemorrhage, neurological injury), or anesthetic change (including increasing/decreasing doses of anesthetics, depth of anesthesia and use of vasoactive drugs). This outcome will be measured in realtime, intraoperatively. Number of participants with change in VEPs associated with increases or decreases of isoflurane and nitrous oxide are reported.

Time frame: Duration of surgery (approximately 3 hours)

Population: Correlation of change in VEPs was qualitatively examined in 18 patients, but not systematically quantified.

ArmMeasureValue (NUMBER)
SightSaver Visual StimulatorCorrelation of Change in VEPs With Identifiable Intraoperative Event18 participants
Secondary

Number of Participants With Change in VEP Signal Strength

Number of participants with change in VEP signal strength. This outcome will be measured in realtime, intraoperatively.

Time frame: Duration of surgery (approximately 3 hours)

Population: Patients who were \>18 years old and were undergoing posterior spine surgery with general anesthesia were approached for the study. Eligible surgeries were microdiscectomy or instrumented fusion (lumbar, thoracic, or thoraco-lumbar). There were no restrictions on the number of surgical levels for inclusion in the study.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SightSaver Visual StimulatorNumber of Participants With Change in VEP Signal Strength18 Participants
Secondary

Number of Participants With Intolerance to the SightSaver Visual Stimulator

Whether the SightSaverTM Visual Stimulator is well tolerated by patients. This outcome will be assessed in the PACU will comprise a clinical exam of the periorbital structures and a patient questionnaire

Time frame: Postoperatively, after recovery from anesthesia (approximately 3 hours after surgery)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SightSaver Visual StimulatorNumber of Participants With Intolerance to the SightSaver Visual Stimulator1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026