Comparison of Neuromuscular Recovery at the Hand and Foot

Neuromuscular Blockade Clinical Trial

Official title:

Comparison of the TOFscan Simultaneous Measures at the Thumb and the First Toe During Recovery of Neuromuscular Function Following Rocuronium Administration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236763
• Other study ID #: 2024-3609
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Louis-Philippe Fortier, MD
• Phone: 514-252-3426
• Email: lpfortier.hmr[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The development of advanced competence in laparoscopic surgery, robotic surgery and the broadening of indications for partial or total laparoscopy techniques created a novel environment where patients need to be deeply paralyzed and positioned in form fitting mattresses to ensure high quality exposure and security in extreme positioning. It is now undisputed that clinical evaluation done any other way than by a objective neuromuscular function monitor may produce faulty conclusions. The elements of the operating setup force anesthesiologists to adapt the way they monitor muscle relaxation since the hands are generally not available for neuromuscular function monitoring. In order to measure properly the level of residual paralysis, the thumb must be able to move freely in a device creating a light preloading on the adductor pollicis allowing to evaluate the force generated during standardized stimulation through accelerometry, the TOFscan device. The corrugator supercilli and orbicularis oculi muscles, an alternate positioning for the accelerometer is sometimes the fallback spot for monitoring. The problem with that muscle is that it does not have the same time curve sensitivity to muscle relaxant than the perilaryngeal muscle have. The investigators are looking for a good representation of the level of patency of the perilaryngeal muscle to ensure that the patient will be able to breath normally after extubation, they must turn to another target. Previous observations have suggested that the monitoring of the hallux flexor muscle could represent a valid alternative. The confirmation of this hypothesis would allow for easy, reproducible, evaluation of the level of muscle relaxation at the perilaryngeal muscles, helping to procure safer conditions for tracheal extubation. Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists during general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Postoperative residual neuromuscular blockade (rNMB), is an adverse event frequently observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications. To prevent those complications, monitoring NMBAs activity and timely and adequate dosage of reversal agents necessitate precise and valid monitoring.

The current literature supports the exclusive use of quantitative measurements of residual paralysis, subjective monitoring caries to much error in evaluating the level of blockade and is responsible for PACU residual paralysis and its complications. It is well accepted that no amount of rNMB is acceptable (TOF < 1) around extubation periods, a necessary step to ensure safety that relies on timely and correct dosage of the reversal agents.

When TOFscan measures are done on partially mobile thumbs, or transducers positioned in non-optimal fashion, the measure observed (deep blockade) will either delay the reversal procedure because of presumed very deep level paralysis or suggest high doses of reversal agents at a significant cost.

The investigators are confident that validating the measures done at the hallux flexor will allow for easy, relevant and valid estimation of residual paralysis and create a safer environment for muscle relaxation reversal and extubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• TOFscan foot
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).

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View Citation

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: 10.1097/000 — View Citation

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. — View Citation

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 Ane — View Citation

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 — View Citation

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. — View Citation

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.000000000 — 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

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. — View Citation

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. — View Citation

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. — View Citation

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, observatio — View Citation

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. — View Citation

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 abstrac — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of neuromuscular blockade (NMB) recovery	Time required for train-of-four (TOF) > 0.9 for the two TOFscans	60 minutes
Secondary	Neuromuscular blockade onset	Time to train-of-four (TOF) count of 0 for both monitors	3 minutes
Secondary	Reversal	Train-of-four ratio (TOF) immediately before reversal agent administration on both monitors	60 minutes
Secondary	Extubation	Train-of-four (TOF) ratio at extubation	1 minute