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Clinical Trials/NCT03319407
NCT03319407TerminatedNot Applicable

EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

Mayo Clinic2 sites in 1 country21 target enrollmentStarted: October 5, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
21
Locations
2
Primary Endpoint
Somatosensory Evoked Potential Monitoring

Study Overview

Brief Summary

Participants to be enrolled in this study will have been scheduled to have laparoscopic genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively. Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries due to intraoperative positioning.

Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine the incidence and potential causes of significant changes in SSEP waveforms and correlate these changes with neurologic status of the brachial plexus after robotic surgery.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients scheduled to undergo robotic assisted laparoscopic genitourinary surgery
  • Patients who are scheduled to have EPAD monitoring as part of their clinical care intraoperatively

Exclusion Criteria

  • Patients with previous history of polyneuropathy, carpal tunnel, ulnar neuropathy, or similar neurological deficiencies

Outcomes

Primary Outcomes

Somatosensory Evoked Potential Monitoring

Time Frame: in the first 24 hours of postoperative period

Recording of somatosensory evoked potential in patients undergoing genitourinary surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert McClain, MD

Principal Investigator

Mayo Clinic

Study Sites (2)

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