EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

Surgery Clinical Trial

Official title:

EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03319407
• Other study ID #: 17-006546
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• EPAD monitoring system
EPAD system will be used as part of routine care

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Somatosensory Evoked Potential Monitoring	Recording of somatosensory evoked potential in patients undergoing genitourinary surgery	in the first 24 hours of postoperative period

External Links

•   Mayo Clinic Clinical Trials