A Comparison Between TOF Watch® SX and Tetragraph®

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947306
• Other study ID #: INT58/20
• Status: Completed
• Start date: August 24, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: June 2021
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• Rocuronium bromide use is anticipated for neuromuscular blockade during surgical procedure

• Upper arms will be freely available during the surgical procedure

Exclusion Criteria:

• Known neuromuscular disease

• Known allergy to Rocuronium bromide

• end-stage liver disease

• chronic kidney disease

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Neuromuscular Monitoring

Intervention

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
• TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)
The TOF Watch® SX is a common used neuromuscular monitor

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios	Bias and Limits of Agreement between the two methodologies using Bland-Altman analysis	Recovery from neuromuscular blockade at the end of the surgical procedure
Secondary	Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios	Normalized TOF Watch® SX train of four ratios will be calculated as the ratio between actual train-of-four ratio and baseline. Bias and Limits of Agreement will be derived using Bland-Altman analysis	Recovery from neuromuscular blockade at the end of the surgical procedure
Secondary	Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8	Normalized TOF Watch® SX train of four ratios will be calculated as the ratio between actual train-of-four ratio and baseline. Bias and Limits of Agreement will be derived using Bland-Altman analysis	Recovery from neuromuscular blockade at the end of the surgical procedure
Secondary	Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios = 0.8	Normalized TOF Watch® SX train of four ratios will be calculated as the ratio between actual train-of-four ratio and baseline. Bias and Limits of Agreement will be derived using Bland-Altman analysis	Recovery from neuromuscular blockade at the end of the surgical procedure
Secondary	Absolute and relative intraobserver variability for TOF Watch® SX and Tetragraph®	Absolute intraobserver variability will be calculated as the absolute difference between pairs of consecutive measurements by the same device. Relative intraobserver variability will be calculated as the ratio between the absolute difference and mean of the measurements.	Recovery from neuromuscular blockade at the end of the surgical procedure