A Comparison Between TOF Watch® SX and Tetragraph®

NCT04947306 | Completed

• 1 other identifier: INT58/20
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Neuromuscular Blockade; Neuromuscular Monitoring

Outcome Measures

Primary Outcomes (1)

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

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

  Recovery from neuromuscular blockade at the end of the surgical procedure

Secondary Outcomes (4)

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

  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

  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

  Recovery from neuromuscular blockade at the end of the surgical procedure

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

  Recovery from neuromuscular blockade at the end of the surgical procedure

Study Arms (1)

All subjects

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)

Interventions

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

Also known as: Electromyographic neuromuscular monitor

All subjects

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

The TOF Watch® SX is a common used neuromuscular monitor

Also known as: Acceleromyographic neuromuscular monitor

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age \> 18 years
• Rocuronium bromide use is anticipated for neuromuscular blockade during surgical procedure
• Upper arms will be freely available during the surgical procedure

You may not qualify if:

• Known neuromuscular disease
• Known allergy to Rocuronium bromide
• end-stage liver disease
• chronic kidney disease

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 1, 2021
• Study Start: August 24, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)