Electrophysiological Comparison of mAP and mADM Using EMG

Surgery Clinical Trial

Official title:

Electrophysiological Comparison of mAP and mADM Using EMG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360825
• Other study ID #: 17-006680
• Status: Completed
• Start date: November 20, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: March 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.

Description:

This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age 18 years or older.

2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).

3. Subject has provided verbal consent

4. BMI <39

Exclusion Criteria

1. Presence of an underlying neuromuscular disease.

2. Presence of renal or hepatic disease.

3. Subject has open skin sores in the locations needed for electrode application (forearms).

4. Patients on oral anticholinesterase, anti-seizure medications, and magnesium sulfate.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• TetraGraph
The TetraGraph is a dedicated neuromuscular stimulator / recorder intended to evoke, record, and analyze muscle action potentials during surgical procedures

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (17)

Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. — View Citation

Brull SJ, Silverman DG. Visual and tactile assessment of neuromuscular fade. Anesth Analg. 1993 Aug;77(2):352-5. — View Citation

Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. — View Citation

CHURCHILL-DAVIDSON HC, RICHARDSON AT. The action of decamethonium iodide (C.10) in myasthenia gravis. J Neurol Neurosurg Psychiatry. 1952 May;15(2):129-33. — View Citation

Claudius C, Viby-Mogensen J. Acceleromyography for use in scientific and clinical practice: a systematic review of the evidence. Anesthesiology. 2008 Jun;108(6):1117-40. doi: 10.1097/ALN.0b013e318173f62f. Review. — View Citation

Connelly NR, Silverman DG, O'Connor TZ, Brull SJ. Subjective responses to train-of-four and double burst stimulation in awake patients. Anesth Analg. 1990 Jun;70(6):650-3. — View Citation

Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. — View Citation

Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. — View Citation

Grayling M, Sweeney BP. Recovery from neuromuscular blockade: a survey of practice. Anaesthesia. 2007 Aug;62(8):806-9. — View Citation

Hemmerling TM, Le N. Brief review: Neuromuscular monitoring: an update for the clinician. Can J Anaesth. 2007 Jan;54(1):58-72. Review. — View Citation

Kim KS, Lew SH, Cho HY, Cheong MA. Residual paralysis induced by either vecuronium or rocuronium after reversal with pyridostigmine. Anesth Analg. 2002 Dec;95(6):1656-60, table of contents. — View Citation

Liang SS, Stewart PA, Phillips S. An ipsilateral comparison of acceleromyography and electromyography during recovery from nondepolarizing neuromuscular block under general anesthesia in humans. Anesth Analg. 2013 Aug;117(2):373-9. doi: 10.1213/ANE.0b013e3182937fc4. Epub 2013 Jul 2. Erratum in: Anesth Analg. 2017 May;124(5):1745. — View Citation

Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4. Review. — View Citation

Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Intraoperative acceleromyography monitoring reduces symptoms of muscle weakness and improves quality of recovery in the early postoperative period. Anesthesiology. 2011 Nov;115(5):946-54. doi: 10.1097/ALN.0b013e3182342840. — View Citation

Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Intraoperative acceleromyographic monitoring reduces the risk of residual neuromuscular blockade and adverse respiratory events in the postanesthesia care unit. Anesthesiology. 2008 Sep;109(3):389-98. doi: 10.1097/ALN.0b013e318182af3b. — View Citation

Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268. — View Citation

Phillips S, Stewart PA, Freelander N, Heller G. Comparison of evoked electromyography in three muscles of the hand during recovery from non-depolarising neuromuscular blockade. Anaesth Intensive Care. 2012 Jul;40(4):690-6. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary performance assessment of TetraGraph device	Agreement between the mAP and mADM EMG based TOF ratios	Duration of surgery
Primary	Primary performance assessment of TetraGraph device	Agreement between the mAP and mADM EMG based TOF counts	Duration of surgery
Secondary	Secondary performance assessment of TetraGraph device	Correlation between stimulation current and T1 twitch height in the two muscles	Duration of surgery
Secondary	Secondary performance assessment of TetraGraph device	Comparison of EMG to the quantitative AMG monitor	Duration of surgery