Trial Outcomes & Findings for Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery (NCT NCT02643615)
NCT ID: NCT02643615
Last Updated: 2017-08-01
Results Overview
Number of Participants with Subtle Intraoperative VEP Changes Observed Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
VEP waveforms recorded every 30 minutes during the entire procedure for up to 6 hours.
Results posted on
2017-08-01
Participant Flow
Participant milestones
| Measure |
VEP Under TIVA
Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
VEP Under Balanced Anesthesia
Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery
Baseline characteristics by cohort
| Measure |
VEP Under TIVA
n=9 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
VEP Under Balanced Anesthesia
n=11 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
56.2 years
STANDARD_DEVIATION 16.1 • n=107 Participants
|
54.5 years
STANDARD_DEVIATION 15.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
11 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: VEP waveforms recorded every 30 minutes during the entire procedure for up to 6 hours.Number of Participants with Subtle Intraoperative VEP Changes Observed Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA
Outcome measures
| Measure |
VEP Under TIVA
n=9 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
VEP Under Balanced Anesthesia
n=11 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins
|
|---|---|---|
|
Efficacy in Detecting Subtle Intraoperative VEP Changes Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 30 minutes during surgery for up to 6 hoursVEP waveforms were evaluated using either present baseline - reproducible positive-negative-positive complex of substantial amplitude (≥2 µV) that appeared 100-200 ms after pulse stimulus onset; marginal Baseline - low amplitude (\<2 µV) reproducible P100 waveform; or absent baseline - no repeatable response present. Any activity of \<0.5 µV was not considered a response. Best derivation for each particular patient was used for monitoring electroretinogram (ERG) recording and confirming the stimulation.
Outcome measures
| Measure |
VEP Under TIVA
n=9 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
VEP Under Balanced Anesthesia
n=11 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins
|
|---|---|---|
|
The Difference in VEP Changes in Amplitude Among Both Groups
|
0.66 micorvolts (µV)
Interval 0.25 to 1.08
|
0.48 micorvolts (µV)
Interval 0.06 to 0.9
|
SECONDARY outcome
Timeframe: every 30 minutes during the entire procedure for up to 6 hoursThe difference in VEP changes in amplitude with a single and double stimuli using the SightSaver visual stimulator under balanced general anesthesia versus TIVA.
Outcome measures
| Measure |
VEP Under TIVA
n=9 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
VEP Under Balanced Anesthesia
n=11 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins
|
|---|---|---|
|
The Difference in VEP Changes in Amplitude Among Both Groups
|
14.21 milliseconds (ms)
Interval 9.5 to 19.0
|
17.94 milliseconds (ms)
Interval 12.8 to 23.0
|
SECONDARY outcome
Timeframe: From start of surgery up to 24 hours after surgeryNumber of participants experiencing adverse events related to the study procedures during prone surgery and 24 hours after surgery under balanced general anesthesia versus TIVA
Outcome measures
| Measure |
VEP Under TIVA
n=9 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
|
VEP Under Balanced Anesthesia
n=11 Participants
Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins
|
|---|---|---|
|
Safety of Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA
|
0 Participants
|
1 Participants
|
Adverse Events
VEP Under TIVA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VEP Under Balanced Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sergio Bergese
The Ohio State University Wexner Medical Center
Phone: 6142933559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place