Comparison of Neuromuscular Recovery at the Hand and Foot

March 6, 2024 updated by: Louis Philippe Fortier, Ciusss de L'Est de l'Île de Montréal

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
        • Contact:
        • Sub-Investigator:
          • Nicolas Lacroix, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of neuromuscular blockade (NMB) recovery
Time Frame: 60 minutes
Time required for train-of-four (TOF) > 0.9 for the two TOFscans
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuromuscular blockade onset
Time Frame: 3 minutes
Time to train-of-four (TOF) count of 0 for both monitors
3 minutes
Reversal
Time Frame: 60 minutes
Train-of-four ratio (TOF) immediately before reversal agent administration on both monitors
60 minutes
Extubation
Time Frame: 1 minute
Train-of-four (TOF) ratio at extubation
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Investigators

  • Principal Investigator: 514-252-3426 Fortier, MD, Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-3609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuromuscular Blockade

Clinical Trials on TOFscan foot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe