Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade

NCT01678625 | Terminated

• 1 other identifier: EH12-158
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting the presence of 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 removed. At the present time, there is only one commercially-available quantitative monitor available in the United States -the TOF-Watch. 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 T4-EMG (EMG = electromyography) that may not be subject to the same limitations as the TOF-Watch AMG (AMG = acceleromyography). In order to study the accuracy of this new device, the T4-EMG will be compared to the current "clinical gold standard", the TOF-Watch.

Conditions

Residual Neuromuscular Blockade

Keywords

Residual neuromuscular blockade; Train-of-four; Acceleromyography; Electromyography

Outcome Measures

Primary Outcomes (1)

• Train-of-four (TOF)ratio

  Train-of-four ratios during recovery of neuromuscular blockade will be compared between the AMG and EMG devices (at a TOF ratio of 0.6, 0.7, 0.8, and 0.9.)

  TOF ratios will be measured for the duration of the operation, approximately 3 hours

Study Arms (2)

Acceleromyography group

Train-of-four ratio calculation (TOF-Watch-SX-Bluestar enterprise)

Device: Train-of-four ratio calculation (T4-EMG)

Electromyography group

Train-of-four ratio calculation (T4-EMG)

Device: Train-of-four ratio calculation (T4-EMG)

Interventions

Train-of-four ratio calculation (T4-EMG) DEVICE

TOF ratios will be compared between the EMG and AMG groups

Acceleromyography group; Electromyography group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for elective surgical procedures under general anesthesia with an expected duration greater than 60 minutes will be enrolled in this study.

You may qualify if:

• American Society of Anesthesiologists Status I to III patients requiring neuromuscular blockade in the operating room will be eligible for enrollment

You may not qualify if:

• \) presence of an underlying neuromuscular disease; 2) use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate); 3) presence of renal or hepatic disease; or 4) procedures preventing access to at least one of the upper extremities.

Sponsors & Collaborators

• Endeavor Health: lead
• T4 Analytics: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Glenn S. Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 5, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (1)