Electrophysiological Comparison of mAP and mADM Using EMG

NCT ID: NCT03360825

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2018-03-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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TetraGraph

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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J. Ross Renew, M.D.

Assistant Professor of Anesthesiology, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J R Renew

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Gatke 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. doi: 10.1034/j.1399-6576.2002.460216.x.

Reference Type BACKGROUND
PMID: 11942873 (View on PubMed)

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. doi: 10.1213/01.ane.0000195543.61123.1f.

Reference Type BACKGROUND
PMID: 16428537 (View on PubMed)

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. doi: 10.1097/00000539-200212000-00033.

Reference Type BACKGROUND
PMID: 12456433 (View on PubMed)

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. doi: 10.1111/j.1399-6576.1997.tb04851.x.

Reference Type BACKGROUND
PMID: 9366929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18635478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18719436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21946094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20442260 (View on PubMed)

Hemmerling TM, Le N. Brief review: Neuromuscular monitoring: an update for the clinician. Can J Anaesth. 2007 Jan;54(1):58-72. doi: 10.1007/BF03021901.

Reference Type BACKGROUND
PMID: 17197470 (View on PubMed)

Brull SJ, Silverman DG. Visual and tactile assessment of neuromuscular fade. Anesth Analg. 1993 Aug;77(2):352-5. doi: 10.1213/00000539-199308000-00024.

Reference Type BACKGROUND
PMID: 8394051 (View on PubMed)

Grayling M, Sweeney BP. Recovery from neuromuscular blockade: a survey of practice. Anaesthesia. 2007 Aug;62(8):806-9. doi: 10.1111/j.1365-2044.2007.05101.x.

Reference Type BACKGROUND
PMID: 17635429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18497614 (View on PubMed)

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. doi: 10.1111/j.1399-6576.2007.01352.x.

Reference Type BACKGROUND
PMID: 17635389 (View on PubMed)

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. doi: 10.1213/00000539-199006000-00012.

Reference Type BACKGROUND
PMID: 2160781 (View on PubMed)

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. doi: 10.1136/jnnp.15.2.129. No abstract available.

Reference Type BACKGROUND
PMID: 14928082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23821356 (View on PubMed)

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. doi: 10.1177/0310057X1204000416.

Reference Type BACKGROUND
PMID: 22813498 (View on PubMed)

Other Identifiers

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17-006680

Identifier Type: -

Identifier Source: org_study_id

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