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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03920670

Recruitment Status Enrolling by invitation

First Posted April 19, 2019

Last update posted January 13, 2020

Study Description

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.

  • Condition or Disease:Residual Neuromuscular Blockade
  • Intervention/Treatment: Device: Neuromuscular stimulation
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Group 1
TetraGraph on dominant arm, ToFscan on non-dominant arm
Device: Neuromuscular stimulation
AMG and EMG neuromuscular blockade monitoring
Active Comparator: Group 2
TetraGraph on non-dominant arm, ToFscan on dominant arm
Device: Neuromuscular stimulation
AMG and EMG neuromuscular blockade monitoring
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • Secondary Outcome Measures: 1. 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
  • 2. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts
Locations

United States, Florida
Mayo Clinic in Florida
Jacksonville

United States, Illinois
NorthShore University HealthSystem
Evanston

Hungary
University of Debrecen
Debrecen

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: J Ross Renew, MD Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03920670 History of Changes
  • Other Study ID Numbers: 18-011298
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: January 13, 2020
  • Last Verified: January 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Mayo Clinic: Neuromuscular Blockade
    ToFscan
    Tetragraph
    AMG
    EMG
  • Additional relevant MeSH terms: Delayed Emergence from Anesthesia