Neuromuscular Blockade, Neuromuscular Monitoring
Conditions
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.
Interventions
DEVICETetragraph® (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
DEVICETOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)
The TOF Watch® SX is a common used neuromuscular monitor
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios | 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
| Measure | Time frame | Description |
|---|---|---|
| Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios | 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 |
| Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8 | 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 |
| Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios ≥ 0.8 | 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 |
| 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. |
Countries
Italy
Outcome results
None listed