Clinical trial NCT04947306: A Comparison Between TOF Watch® SX and Tetragraph®
Official title: A Comparison of Accelerometric Monitoring by TOF Watch® SX and Electromyographic Monitoring by Tetragraph® for Recovery From Neuromuscular Blockade
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Neuromuscular Monitoring
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios
timeFrame: Recovery from neuromuscular blockade at the end of the surgical procedure
Secondary outcomes:
measure: Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios
timeFrame: Recovery from neuromuscular blockade at the end of the surgical procedure
measure: Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8
timeFrame: Recovery from neuromuscular blockade at the end of the surgical procedure
measure: Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios ≥ 0.8
timeFrame: Recovery from neuromuscular blockade at the end of the surgical procedure
measure: Absolute and relative intraobserver variability for TOF Watch® SX and Tetragraph®
timeFrame: Recovery from neuromuscular blockade at the end of the surgical procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Mi
Study officials:
References: