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

NCT02643615 | Completed Results FDA Device

• 1 other identifier: 2014H0208
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Optic Neuropathy

Keywords

Visual Evoked Potentials

Outcome Measures

Primary Outcomes (1)

• Efficacy in Detecting Subtle Intraoperative VEP Changes Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA.

  Number of Participants with Subtle Intraoperative VEP Changes Observed Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA

  VEP waveforms recorded every 30 minutes during the entire procedure for up to 6 hours.

Secondary Outcomes (3)

• The Difference in VEP Changes in Amplitude Among Both Groups

  Every 30 minutes during surgery for up to 6 hours

• The Difference in VEP Changes in Amplitude Among Both Groups

  every 30 minutes during the entire procedure for up to 6 hours

• Safety of Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA

  From start of surgery up to 24 hours after surgery

Study Arms (2)

VEP under TIVA

EXPERIMENTAL

Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance

Device: VEP under TIVA; Drug: Propofol

VEP under balanced anesthesia

EXPERIMENTAL

Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia

Device: VEP under balanced anesth.; Drug: Desflurane

Interventions

VEP under TIVA DEVICE

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 TIVA

VEP under balanced anesth. DEVICE

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.

VEP under balanced anesthesia

Propofol DRUG

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.

Also known as: Diprivan

VEP under TIVA

Desflurane DRUG

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.

Also known as: Suprane

VEP under balanced anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Dr. Sergio Bergese
• Organization: The Ohio State University Wexner Medical Center

sergio.bergese@osumc.edu

6142933559

Study Officials

• Sergio D Bergese, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 31, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 1, 2017
• Results First Posted: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)