Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs

The purpose of this research is to compare the performance of acceleromyograph and electromyograph-based quantitative neuromuscular monitors when the arms are tucked for surgical positioning.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cystoscopy
• Intervention / Treatment: Other: Observation of EMG and AMG readings

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgery and requiring general anesthesia without administration of neuromuscular blocking agents.

Description

Inclusion Criteria:

• Patients willing to participate and provide an informed consent.
• Patients undergoing elective surgical procedures that require general anesthesia without use of NMBA agents administered intraoperatively, and tucked arms.
• Anticipated surgery duration < 120 minutes.

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 having surgery that would involve prepping the arm into the sterile field.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Procedure without neuromuscular blockade	Other: Observation of EMG and AMG readings; Simultaneous readings from electromyograph and acceleromyograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy and precision	Accuracy and precision of train-of-four ratios measured simultaneously by two quantitative neuromuscular monitors every minute among 40 patients undergoing surgery of at least 30 min duration (roughly 1200 measurements) in which the arms are tucked and in the absence of neuromuscular blocking agents. In the absence of neuromusuclar blocking agents, the expected train-of-four ratio is 1.0. Accuracy of each monitor will be assessed by how close measuremetns are to 1.0 while precision will be assessed by the variability of the measured responses in all patients undergoing procedure.	120 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: J. Ross Renew, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-011159

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
• product manufactured in and exported from the U.S.: No