Neuromuscular Monitoring:TOFCuff Versus EMG

NCT04282213 | Completed

• 1 other identifier: NMT2020
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanomyography (MMG) is considered the gold-standard for neuromuscular blockade (NMB) monitoring. However, it is quite bulky and difficult to use on a routine basis. Therefore, alternative methods like Acceleromyography (AMG), Electromyography (EMG) and the TOF-CUFF method have been developed. The aim of this study was to compare the TOF-Cuff monitor and Electromyography (EMG-NMT module with the CARESCAPE B450 monitor) data following rocuronium-induced neuromuscular blockade and its reversal.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (10)

• TOFR (Train Of Four Ratio)

  For this measurement, patient is stimulated with four twitches at a known stimulation current. Each twitch is performed every 500ms. The neuromuscular response for each twitch is gathered. Train Of Four ratio consists of the weighting of the fourth stimulus against the first stimulus. It can be calculated also as a percentage.

  Baseline

• Counts

  When performing the Train Of Four (TOF) measurement, count of the twitches that are higher than 0.

  Baseline

• PTC

  Once patient is in a deep neuromuscular blockade, all twitches from Train Of Four (TOF) measurement are 0. In order to evaluate the neuromuscular response, Post Tetanic Count (PTC) measurement is performed. PTC is splitted in two steps. First, during 5 seconds a tetanic stimulation is performed at 50Hz. If no response is elicited, after a pause of 3 seconds 15 single-twitch stimualtion at 1Hz are performed. PTC value is the count of the single-twitches that are higher than 0.

  Baseline

• T1

  For Train Of Four (TOF) measurement, amplitude of the first neuromuscular stimulation response. Units depend on the measurement techniques.

  Baseline

• T2

  For Train Of Four (TOF) measurement, amplitude of the second neuromuscular stimulation response. Units depend on the measurement techniques.

  Baseline

• T3

  For Train Of Four (TOF) measurement, amplitude of the third neuromuscular stimulation response. Units depend on the measurement techniques.

  Baseline

• T4

  For Train Of Four (TOF) measurement, amplitude of the fourth neuromuscular stimulation response. Units depend on the measurement techniques.

  Baseline

• PID

  Diastolic pressure in mmHg

  Baseline

• PIS

  Systolic pressure in mmHg

  Baseline

• PIM

  Mean pressure in mmHg

  Baseline

Secondary Outcomes (1)

• Temperature

  Baseline

Study Arms (2)

Control samples

For each case, neuromuscular measurements gathered with GE CARESCAPE B450 monitor (E-NMT module).

Case samples

For each case, neuromuscular measurements gathered with TOFCuff monitor.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients American Society of Anesthesiologist (ASA) I-II, between 18-65 years and scheduled for elective surgery under general anesthesia.

You may qualify if:

• ASA I-II
• Patients who give their written informed consent
• Elective surgery under general anesthesia that according to the anesthetic plan muscle relaxants will be administered

You may not qualify if:

• Patients who refuse to give their informed consent
• Patients who present any of the contraindications for the devices used in the study
• Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or breast-feeding
• Patients with the following criteria: upper limb peripheral vascular pathologies, a difficult airway, myasthenia gravis and other neuromuscular diseases, use of medication that may alter NMT

Sponsors & Collaborators

• Servei Central d'Anestesiologia: lead

Study Sites (1)

Centro Médico Teknon

Barcelona, 08022, Spain

Location

Related Publications (5)

• Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.

  PMID: 19910616 BACKGROUND

• Veiga Ruiz G, Garcia Cayuela J, Orozco Montes J, Parreno Caparros M, Garcia Rojo B, Aguayo Albasini JL. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): A comparative study with mechanomyography and invasive blood pressure. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):560-567. doi: 10.1016/j.redar.2017.03.013. Epub 2017 Jun 27. English, Spanish.

  PMID: 28662770 BACKGROUND

• Rodiera J, Serradell A, Alvarez-Gomez JA, Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function. Acta Anaesthesiol Scand. 2005 Nov;49(10):1552-8. doi: 10.1111/j.1399-6576.2005.00777.x.

  PMID: 16223405 BACKGROUND

• Checketts MR, Jenkins B, Pandit JJ. Implications of the 2015 AAGBI recommendations for standards of monitoring during anaesthesia and recovery. Anaesthesia. 2017 Jan;72 Suppl 1:3-6. doi: 10.1111/anae.13736. No abstract available.

  PMID: 28044335 BACKGROUND

• Dahaba AA, von Klobucar F, Rehak PH, List WF. The neuromuscular transmission module versus the relaxometer mechanomyograph for neuromuscular block monitoring. Anesth Analg. 2002 Mar;94(3):591-6; table of contents. doi: 10.1097/00000539-200203000-00021.

  PMID: 11867381 BACKGROUND

Study Officials

• Lorena Silva Gil, MD

  Servei d'Anestesiologia Centro Médico Teknon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: January 15, 2020
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)