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Completed

NCT Number: NCT04947306

A Comparison Between TOF Watch® SX and Tetragraph®

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

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Key information

Conditions

Neuromuscular Blockade Neuromuscular Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetragraph® (Senzime, Uppsala, Sweden)

Device

The Tetragraph® is a recently marketed electromyographic neuromuscular monitor that uses a disposable electrode array (TetraSens) that combines stimulating and recording electrodes

Other names: Electromyographic neuromuscular monitor

TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)

Device

The TOF Watch® SX is a common used neuromuscular monitor

Other names: Acceleromyographic neuromuscular monitor

Primary outcomes

  1. Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios

    Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure

    Bias and Limits of Agreement between the two methodologies using Bland-Altman analysis

Secondary outcomes

  1. Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios

    Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure

    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

  2. Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8

    Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure

    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

  3. Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios ≥ 0.8

    Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure

    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

  4. Absolute and relative intraobserver variability for TOF Watch® SX and Tetragraph®

    Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure

    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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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