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A Comparison Between TOF Watch® SX and Tetragraph®

Completed
Conditions
Neuromuscular Monitoring
Neuromuscular Blockade
Interventions
Device: Tetragraph® (Senzime, Uppsala, Sweden)
Device: TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)
Registration Number
NCT04947306
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
All subjectsTetragraph® (Senzime, Uppsala, Sweden)Adult patients \>18 years of age, who are scheduled to undergo any elective procedure under general anesthesia at our Institution in which the administration of rocuronium for neuromuscular blockade is anticipated. All participants will be monitored with both TOF Watch and Tetragraph neuromuscular monitors.
All subjectsTOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)Adult patients \>18 years of age, who are scheduled to undergo any elective procedure under general anesthesia at our Institution in which the administration of rocuronium for neuromuscular blockade is anticipated. All participants will be monitored with both TOF Watch and Tetragraph neuromuscular monitors.
Primary Outcome Measures
NameTimeMethod
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratiosRecovery from neuromuscular blockade at the end of the surgical procedure

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

Secondary Outcome Measures
NameTimeMethod
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8Recovery 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

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

Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratiosRecovery 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

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

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

🇮🇹

Milan, Mi, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milan, Mi, Italy
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