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

Not Applicable

Completed

• Conditions: Residual Neuromuscular Blockade
• Interventions: Device: TetraGraph (TG); Device: ToFscan (TS)

• Registration Number: NCT03920670
• Lead Sponsor: Mayo Clinic

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 available

Study Timeline

• Study First Submitted: 2019-02-13
• Study Start: 2019-02-28
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-19
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-03
• Results First Submitted: 2021-03-01
• Results First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Results First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ToFscan (TS)	TetraGraph (TG)	ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
Tetragraph (TG)	TetraGraph (TG)	TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
ToFscan (TS)	ToFscan (TS)	ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
Tetragraph (TG)	ToFscan (TS)	TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand

Primary Outcome Measures

Name	Time	Method
Mean Train-of-Four Ratios (TOFR's)	baseline, after 5 minutes, after + 10 minutes	Train-of-four ratios is the ratio of the fourth muscle response to the first one.

Trial Locations

Locations (3)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

University of Debrecen; 🇭🇺 Debrecen, Hungary

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States