NCT04947306

A Comparison Between TOF Watch® SX and Tetragraph®

A Comparison of Accelerometric Monitoring by TOF Watch® SX and Electromyographic Monitoring by Tetragraph® for Recovery From Neuromuscular Blockade

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This observational study was designed to assess the agreement between the recently marketed electromyographic neuromuscular blockade monitor Tetragraph® (Senzime, Uppsala, Sweden) and the TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland), an accelerometric neuromuscular blockade monitor frequently used in clinical practice

Detailed description

Before the induction of general anesthesia both monitors will be placed in the same arm. After induction of general anesthesia and before neuromuscular blocking agent administration both devices will be consecutively calibrated and a baseline measurement will be obtained. During the surgical procedure the investigators will monitor neuromuscular function with one of the two devices. Then the investigators will switch the device used as a guide between subsequent patients. The protocol will start as soon as the leading device will register a train-of-four ratio (TOFr) ≥ 0.2. During the protocol a comparison between the two devices will be conducted as soon as the device used as a guide will display a TOFr ≥ 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1. For each of the TOFr reported, we will deliver two subsequent TOF stimulations with the guiding device followed by two TOF stimulations with the other monitor. Both the stimulations delivered by each device and the two consecutive stimulations delivered by different monitors will be conducted 20 sec from one another. Stimulations with the same device will be used to assess intraobserver variability for each methodology, while the second and the third measurements (consecutive stimulations with different devices) will be used to assess agreement between them. The protocol will end when the leading device will show a TOFr ≥ 1.0, or if, at the end of the surgical procedure, acceleromyographic TOFr will be \> 0.9.

Conditions

• Neuromuscular Blockade
• Neuromuscular Monitoring

Interventions

Type	Name	Description
DEVICE	Tetragraph® (Senzime, Uppsala, Sweden)	The Tetragraph® is a recently marketed electromyographic neuromuscular monitor that uses a disposable electrode array (TetraSens) that combines stimulating and recording electrodes
DEVICE	TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)	The TOF Watch® SX is a common used neuromuscular monitor

Timeline

• Start date: 2020-08-24
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2021-07-01
• Last updated: 2021-07-01

Locations

1 site across 1 country: Italy