Comparison of Adductor Pollicis and Abductor Digiti Minimi Muscles (Thumb Vs. Fifth Digit) As Sites for Neuromuscular Monitoring with Electromyography

November 13, 2024 updated by: Tamas Vegh, MD
This study aims to evaluate the performance of the TetraGraph on two muscle groups: the adductor pollicis and the abductor digiti minimi. Theese muscles are located on the arms. Key time points for assessment will include the onset of neuromuscular blockade and the recovery from rocuronium blockade using sugammadex.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Introduction Residual neuromuscular blockade is a common occurrence in the post-anesthesia care unit (PACU) when neuromuscular blocking agents (NMBAs) have been used in the operating room. The only method of reliably detecting residual neuromuscular blockade is through the use of quantitative neuromuscular monitors. Unfortunately, several barriers exist that have prevented the widespread use of these devices. For instance, there is a paucity of quantitative neuromuscular monitors commercially available. Also, two modalities of quantitative monitoring, kinemyography and acceleromyography, rely on movement of the muscles of interest, a characteristic frequently compromised during patient positioning for surgical procedures in which the patient's arms are secured under surgical drapes (laparoscopic, bariatric, robotic, spine, and neurosurgical procedures) or in uncooperative awake patients in the PACU or intensive care unit (ICU). The aim of this investigation is to determine the different muscle sensitivities to NMBA and reversal agents by comparing responses at two different monitoring sites as measured with a new quantitative monitor. EMG measures electrical activity within the muscle following peripheral nerve stimulation and is unaffected by involuntary patient motion or by restricted muscle movements from surgical positioning. We plan to compare measurements obtained with two TetraGraph devices, one monitoring the adductor pollicis (thumb) muscle and the other monitoring adductor digiti minimi (5th digit) muscle, during onset, maintenance, and recovery of neuromuscular blockade. This will include monitoring every 20 sec for onset of blockade (defined as time from Train-of-Four ratio, TOFR=1.0 until Train-of-four count, TOFC=0) following rocuronium administration, during maintenance of neuromuscular block as required by surgical conditions, and following reversal administration until adequate recovery is documented (train-of-four ratio, TOFR ≥0.9).

Medication of the patient, surgical procedure

Upon entering the operating room, all patients underwent monitoring using electrocardiograms, noninvasive blood pressure measurements, and pulse oximetry. An intravenous catheter was inserted into either the forearm or the dorsal vein. Anesthesia was initiated with intravenous fentanyl (2.0 mg/kg) and propofol (1.5 to 2.5 mg/kg) and was maintained using sevoflurane (end-tidal concentration of 1.0 to 1.3%) in an air-oxygen mixture, with additional fentanyl given as needed. Before tracheal intubation, the patients were manually ventilated with 100% oxygen via facemask. Oxygen saturation was kept above 96%, and normocapnia was maintained. A forced air warming system (Bair Hugger, Arizant Healthcare Inc., Eden Prairie, Minnesota, USA) was used to keep the body temperature at or above 36°C. Intraoperative hypotension was treated with ephedrine, norepinephrine, or a fluid bolus, according to clinical indications. Ondansetron 4mg IV was routinely administered to prevent postoperative nausea and vomiting.

Neuromuscular Management Before the induction of anesthesia, after appropriate skin cleaning, single-use surface TetraGraph electrodes were placed over the ulnar nerve and thumb to assess the adductor pollicis response on one hand, and over the ulnar nerve and fifth digit to assess the abductor digiti minimi response on the other hand. Following the induction of anesthesia, train-of-four (TOF) stimulation was applied to both muscle groups at a frequency of 2 Hz for 1.5 seconds every 15 seconds, after the automated calibration of supramaximal current and responses. Once stable baseline TOF responses were established, all patients received 0.6 mg/kg of rocuronium intravenously. Measurements were taken every five minutes during the intraoperative period until the administration of sugammadex. After that, we monitored the spontaneous recovery of the rocuronium-induced neuromuscular block until three consecutive TOF counts of 2 (TOFC2) were observed at both monitoring sites. Additional doses of rocuronium (0.1-0.2 mg/kg) were administered as necessary to maintain a Train of Four (TOF) count of ≤2. At the end of the surgery, sugammadex was given at a dose of 2 mg/kg. After administering sugammadex, measurements were taken every 20 seconds until the patient was extubated. Following the measurements obtained with both devices at the specified intervals, and once the TOF ratio exceeded 0.9, the devices were disconnected, and the patients continued along the standard recovery pathway.

Rescue medication After pharyngoscopy, rescue medication is given if necessary, i.e. below 90% TOF, depending on the type of muscle relaxant used. If an aminosteroid muscle relaxant is used, the patient is given 2 mg/kg sugammadex, while if a benzylisoquinoline muscle relaxant is used, 0.05 mg/kg neostigmine and 0.015 mg/kg atropine are administrated to antagonise the drug effect.

Study Type

Observational

Enrollment (Estimated)

46

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

  • Hungary
      • Debrecen, Hungary
        • Completed
        • University of Debrecen, Debrecen, Hajdú-Bihar 4008
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Recruiting
        • University of Debrecen, Department of Anesthesiology and Intensive Care
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients who receive a muscle relaxant (rocuronium bromide) for their operation to aid intubation and surgical exploration.

Description

Inclusion Criteria:

  • Age > or = 18 years old
  • Patients willing to participate and provide an informed consent
  • Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

Exclusion Criteria:

  • Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
  • Patients with systemic neuromuscular diseases such as myasthenia gravis.
  • Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
  • Patients having surgery that would involve prepping the arm into the sterile field.
  • Patients receiving a rapid sequence induction.
  • Patients allergic to rocuronium or sugammadex.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of recovery following sugammadex administration as recorded simultaneously from the hand (adductor pollicis) and fifth digit (abductor digiti minimi) muscles
Time Frame: depends on the depth of the neuromuscular block, a maximum of about 20 minutes
the time in seconds between the administration of the suggamedex and TOF 100%.
depends on the depth of the neuromuscular block, a maximum of about 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative residual weakness
Time Frame: one hour after extubation
The secondary endpoint is the incidence of postoperative residual weakness at the time of extubation at a center that predominately utilizes quantitative monitoring (defined as TOFR <0.90).
one hour after extubation

Collaborators and Investigators

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

Sponsor

Tamas Vegh, MD

Investigators

  • Study Director: Béla Fülesdi, MD, Phd, DSc, Department of Anesthesiology and Intensive Care University of Debrecen

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

Helpful Links

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)

October 18, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AITT 2023/7
  • DE RKEB/IKEB 6656-2023 (Other Identifier: Regional and Institutional Ethics Committee University of Debrecen Clinical Center)
  • BM/26645-1/2024 (Other Identifier: Ministry of Interior, Research Council Mailing)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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