Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

• ClinicalTrials.gov Identifier: NCT03920670
• Recruitment Status: Completed
• First Posted: April 19, 2019
• Last Update Posted: January 29, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): J. Ross Renew, M.D., Mayo Clinic

Tracking Information

• First Submitted Date: February 13, 2019
• First Posted Date: April 19, 2019
• Last Update Posted Date: January 29, 2021
• Actual Study Start Date: February 28, 2019
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 31, 2019)

Consistency in values obtained by ToFscan and TetraGraph [ Time Frame: up to 10 hours postoperatively ]

Obtain ToFscan values and TetraGraph values simultaneously in the recovery period simultaneously (same measuring units).

Original Primary Outcome Measures (submitted: April 15, 2019)

Consistency in values obtained by ToFscan and TetraGraph [ Time Frame: up to 10 hours postoperatively ]

Obtain ToFscan values and TetraGraph values simultaneously in the recovery period simultaneously.

Current Secondary Outcome Measures (submitted: April 15, 2019)

• Number of patients with incomplete neuromuscular blockade reversal [ Time Frame: up to 10 hours postoperatively ]
  Identify patients who demonstrate TOF reading below 90% in the recovery period
• Patient's reported discomfort with use of devices [ Time Frame: up to 10 hours postoperatively ]
  Number of patients reporting discomfort associated with use of either device

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
• Official Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
• Brief Summary: The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Residual Neuromuscular Blockade

Intervention

Device: Neuromuscular stimulation

AMG and EMG neuromuscular blockade monitoring

Study Arms

• Experimental: Group 1
  TetraGraph on dominant arm, ToFscan on non-dominant arm
  Intervention: Device: Neuromuscular stimulation
• Active Comparator: Group 2
  TetraGraph on non-dominant arm, ToFscan on dominant arm
  Intervention: Device: Neuromuscular stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2019): 120
• Original Estimated Enrollment (submitted: April 15, 2019): 30
• Actual Study Completion Date: November 30, 2020
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• Age > or = 18 years old
• Patients willing to participate and provide an informed consent
• Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

• Patients with unilateral 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hungary, United States

Administrative Information

• NCT Number: NCT03920670
• Other Study ID Numbers: 18-011298
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Responsible Party: J. Ross Renew, M.D., Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: J Ross Renew, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: January 2021