Surgery
Conditions
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.
Interventions
DEVICEEPAD monitoring system
EPAD system will be used as part of routine care
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Somatosensory Evoked Potential Monitoring | in the first 24 hours of postoperative period | Recording of somatosensory evoked potential in patients undergoing genitourinary surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observation All participants will be monitored with EPAD system
EPAD monitoring system: EPAD system will be used as part of routine care | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Observation |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Somatosensory Evoked Potential Monitoring
Recording of somatosensory evoked potential in patients undergoing genitourinary surgery
Time frame: in the first 24 hours of postoperative period
Population: Study terminated prematurely. Data was not collected.