Comparison of Neuromuscular Recovery at the Hand and Foot

NCT06236763 | Recruiting DMC

• 1 other identifier: 2024-3609
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Gold standard for neuromuscular blockade evaluation is accelerometry in three dimensions at the thumb. There are many times that measurement at the hand can be falsely under-estimated intraoperatively secondary to constriction of the upper extremities. We believe that installing the same accelerometer at the first toe will give us similar readings for both neuromuscular blockade and recovery from rocuronium administration. This study focuses on agreement values between two accelerometers installed on the hand and at on the foot.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Time of neuromuscular blockade (NMB) recovery

  Time required for train-of-four (TOF) \> 0.9 for the two TOFscans

  60 minutes

Secondary Outcomes (3)

• Neuromuscular blockade onset

  3 minutes

• Reversal

  60 minutes

• Extubation

  1 minute

Study Arms (1)

Observation and control

Two accelerometers will be applied on each patient; observation (foot) and control (hand, also the gold standard). Agreement values will be compared between these two monitors.

Device: TOFscan foot

Interventions

TOFscan foot DEVICE

TOFscan will be applied on the foot and recovery from neuromuscular blockade will be observed over time. These will be compared with the control (TOFscan at the hand) on the same patient (gold standard monitor).

Observation and control

Eligibility Criteria

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

Study Population

Any patient scheduled for more than 2 hours extra cavitary surgery where muscle relaxation spontaneous reversal will not interfere with the completion of the planned surgical procedure.

You may qualify if:

• ASA 1-3 patients
• Elective surgery
• Undergoing general anesthesia with rocuronium induced NMB
• BMI \< 36 kg.m-2
• Age \> 18 years old
• French or English speaking patient

You may not qualify if:

• Renal or hepatic dysfunction
• Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
• Neuromuscular disease
• Peripheral arterial disease (suspected, known or investigated)
• Calcium channel anomalies
• Hypothermia (\< 35C)
• Hyper/hypomagnasemia
• Allergy to any drug used in the study protocol
• Patient refusal

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Related Publications (14)

• Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.

  PMID: 28044330 RESULT

• Unterbuchner C, Ehehalt K, Graf B. [Algorithm-based preventive strategies for avoidance of residual neuromuscular blocks]. Anaesthesist. 2019 Nov;68(11):744-754. doi: 10.1007/s00101-019-00677-6. German.

  PMID: 31650189 RESULT

• D'Honneur G, Guignard B, Slavov V, Ruggier R, Duvaldestin P. Comparison of the neuromuscular blocking effect of atracurium and vecuronium on the adductor pollicis and the geniohyoid muscle in humans. Anesthesiology. 1995 Mar;82(3):649-54. doi: 10.1097/00000542-199503000-00006.

  PMID: 7879933 RESULT

• Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.

  PMID: 25902322 RESULT

• 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.

  PMID: 18635478 RESULT

• Errando CL, Garutti I, Mazzinari G, Diaz-Cambronero O, Bebawy JF; Grupo Espanol De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: observational cross-sectional study of a multicenter cohort. Minerva Anestesiol. 2016 Dec;82(12):1267-1277. Epub 2016 May 27.

  PMID: 27232277 RESULT

• Saager L, Maiese EM, Bash LD, Meyer TA, Minkowitz H, Groudine S, Philip BK, Tanaka P, Gan TJ, Rodriguez-Blanco Y, Soto R, Heisel O. Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study. J Clin Anesth. 2019 Aug;55:33-41. doi: 10.1016/j.jclinane.2018.12.042. Epub 2018 Dec 27.

  PMID: 30594097 RESULT

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.

  PMID: 30130260 RESULT

• Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jorgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. doi: 10.1097/00000542-198510000-00015. No abstract available.

  PMID: 4037404 RESULT

• 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.

  PMID: 8394051 RESULT

• Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.

  PMID: 29200077 RESULT

• Kirov K, Motamed C, Dhonneur G. Differential sensitivity of abdominal muscles and the diaphragm to mivacurium: an electromyographic study. Anesthesiology. 2001 Dec;95(6):1323-8. doi: 10.1097/00000542-200112000-00008.

  PMID: 11748387 RESULT

• Plaud B, Debaene B, Donati F. The corrugator supercilii, not the orbicularis oculi, reflects rocuronium neuromuscular blockade at the laryngeal adductor muscles. Anesthesiology. 2001 Jul;95(1):96-101. doi: 10.1097/00000542-200107000-00019.

  PMID: 11465590 RESULT

• Dhonneur G, Kirov K, Slavov V, Duvaldestin P. Effects of an intubating dose of succinylcholine and rocuronium on the larynx and diaphragm: an electromyographic study in humans. Anesthesiology. 1999 Apr;90(4):951-5. doi: 10.1097/00000542-199904000-00004.

  PMID: 10201662 RESULT

Study Officials

• 514-252-3426 Fortier, MD

  Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis-Philippe Fortier, MD

CONTACT

514-252-3426; lpfortier.hmr@ssss.gouv.qc.ca

Nadia Godin

CONTACT

514-252-3426; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Associate Professor, Anesthesiologist, Chief officer perioperative and surgical activities, Department of Anesthesiology and Pain Medicine at University of Montréal

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 1, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)