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

NCT06805032 | Enrolling By Invitation

• 1 other identifier: 24-011159
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Procedure without neuromuscular blockade

Other: Observation of EMG and AMG readings

Interventions

Observation of EMG and AMG readings OTHER

Simultaneous readings from electromyograph and acceleromyograph

Procedure without neuromuscular blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Study Officials

• J. Ross Renew, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)