Acceleromyographic Assessment of Neuromuscular Blockade: TOF-Watch-SX Versus TOFscan

NCT02433769 | Unknown Phase 4

• 1 other identifier: EH14-266
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle relaxants are administered to most patients undergoing general anesthesia in order to facilitate the placement of an endotracheal tube and improve operating conditions. Despite routine reversal of these agents, many patients arrive in the recovery room with evidence of residual muscle weakness. Many studies have demonstrated that residual neuromuscular blockade (weakness) is a common occurrence after surgery. The only method of reliably detecting the presence of perioperative neuromuscular blockade is through the use of quantitative neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the endotracheal tube can be safely removed. At the present time, there is only one commercially-available stand-alone quantitative monitor available in the United States -the TOF-Watch (an acceleromyography device). It is not used by many clinicians because it requires experience to obtain accurate results, is expensive, and is subject to interference by factors in the operating room. The aim of this investigation is to examine a new quantitative monitor, the TOFscan (a new three dimensional acceleromyography device). In order to study the accuracy of this new device, the TOFscan will be compared to the current "clinical gold standard", the TOF-Watch-SX.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Train-of-four (TOF) ratio 0.7

  Data from the TOFscan will be compared to the TOF-Watch-SX at a TOF ratio of 0.7 (when the TOF-Watch-SX reads 0.7 (gold standard), the reading from the TOFscan will be recorded and compared

  from the start of surgery until 1 hour after admission to the recovery room

Secondary Outcomes (2)

• Train-of-four (TOF) ratio 0.6

  from the start of surgery until 1 hour after admission to the recovery room

• train-of-four (TOF) ratio 0.9

  from the start of surgery until 1 hour after admission to the recovery room

Study Arms (2)

TOf-Watch-SX

ACTIVE COMPARATOR

Train-of-four (TOF) ratios will be measured with the TOF-Watch-SX and compared to TOF ratios measured simultaneously with the TOFscan

Device: TOF-Watch-SX

TOFscan

EXPERIMENTAL

Train-of-four (TOF) ratios obtained from the TOFscan will be compared to TOF ratios measured simultaneously with the TOF-Watch-SX

Device: TOFscan

Interventions

TOFscan DEVICE

Data from the TOFscan will be compared to simultaneously measured data from the TOF-Watch-SX ("gold standard")

TOFscan

TOF-Watch-SX DEVICE

Data from the TOF-Watch-SX will be compared to simultaneously measured data from the TOFscan

TOf-Watch-SX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to III patients requiring neuromuscular blockade in the operating room

You may not qualify if:

• presence of an underlying neuromuscular disease
• use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate)
• presence of renal or hepatic disease
• procedures preventing access to both of the upper extremities.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

US (1)