Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
- Conditions
- Residual Neuromuscular Blockade
- Interventions
- Device: TetragraphDevice: ToFscan
- Registration Number
- NCT04352140
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.
- Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
- Patients with systemic neuromuscular diseases such as myasthenia gravis
- Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
- Patients having surgery that would involve prepping the arm or leg into the sterile field
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dominant hand Tetragraph Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand Dominant hand ToFscan Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand Non-dominant hand Tetragraph Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand Non-dominant hand ToFscan Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
- Primary Outcome Measures
Name Time Method Accuracy of Values Between Tetragraph and ToFscan Up to 1 hour postoperatively The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan
- Secondary Outcome Measures
Name Time Method Incidence of Residual Neuromuscular Blockade Up to 1 hour postoperatively Number of patients with train of four ratio \< 0.9 after administration of reversal agent.
Trial Locations
- Locations (3)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Université de Lorraine, CHU de Brabois
🇫🇷Vandœuvre-lès-Nancy, France
University of Debrecen
🇭🇺Debrecen, Hungary
Mayo Clinic in Florida🇺🇸Jacksonville, Florida, United States