An observational study in Neuromuscular Blockade and Neuromuscular Monitoring, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-01.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational
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
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.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
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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.
Exclusion Criteria:
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.
Device: Tetragraph® (Senzime, Uppsala, Sweden) · Device: TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)
The Tetragraph® is a recently marketed electromyographic neuromuscular monitor that uses a disposable electrode array (TetraSens) that combines stimulating and recording electrodes
Also known as: Electromyographic neuromuscular monitor
The TOF Watch® SX is a common used neuromuscular monitor
Also known as: Acceleromyographic neuromuscular monitor
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios
Bias and Limits of Agreement between the two methodologies using Bland-Altman analysis
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
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
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
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
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
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
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
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.
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
Plan to share: No
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano