Trial Outcomes & Findings for A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia (NCT NCT02563028)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Duration of surgery (approximately 3 hours)

Results posted on

2022-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intraoperative Monitoring Device In this study, the FDA-cleared, non-invasive mask called SightSaverTM Visual Stimulator is used as an additional monitor to identify potential changes in the visual system during surgery
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intraoperative Monitoring Device In this study, the FDA-cleared, non-invasive mask called SightSaverTM Visual Stimulator is used as an additional monitor to identify potential changes in the visual system during surgery
Overall Study Lack of equipment	1
Overall Study Unable to elicit VEP post induction	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evoked Response Photic Stimulator n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	54 Years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	SightSaver Visual Stimulator n=18 Participants 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. SightSaver Visual Stimulator: Evoked response photic stimulator
Number of Participants With Presence of VEPs	18 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	SightSaver Visual Stimulator n=18 Participants 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. SightSaver Visual Stimulator: Evoked response photic stimulator
Number of Participants With Change in VEP Signal Strength	18 Participants

SECONDARY outcome

Timeframe: Duration of surgery (approximately 3 hours)

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

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.

Outcome measures

Outcome measures
Measure	SightSaver Visual Stimulator n=18 Participants 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. SightSaver Visual Stimulator: Evoked response photic stimulator
Correlation of Change in VEPs With Identifiable Intraoperative Event	18 participants

SECONDARY outcome

Timeframe: Postoperatively, 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

Outcome measures

Outcome measures
Measure	SightSaver Visual Stimulator n=18 Participants 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. SightSaver Visual Stimulator: Evoked response photic stimulator
Number of Participants With Intolerance to the SightSaver Visual Stimulator	1 Participants

Adverse Events

SightSaver Visual Stimulator

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SightSaver Visual Stimulator n=20 participants at risk 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. SightSaver Visual Stimulator: Evoked response photic stimulator Adverse event total: 0/20 0%
Skin and subcutaneous tissue disorders Minor periorbital skin irritation.	5.0% 1/20 • Number of events 1 • Patients were followed up until Post Anesthesia Care Unit (PACU) by the anesthesiologists. A survey was filled out by the anesthesiologists to assure the wellness of the patient. Up to 24 hours after surgery. This is a pilot study (non-invasive) where there was no treatment involved thus there were no interventions. There was a 5% incidence of Adverse Event.

Additional Information

Valeria Rotundo

Hospital for Special Surgery

Phone: 212-774-7885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place