A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study

A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study - A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053918

Enrollment

Registered

2024-03-20

Start date

2024-04-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with upper gastrointestinal, lower gastrointestinal, hepatobiliary, gynecologic, or urologic diseases undergoing laparoscopic surgery in the 0 degrees pronation in both upper limb position

Interventions

The electromyography electrode, NM-345Y, is attached such that the line connecting the centers of the anode and cathode of the stimulating electrode crosses the ulnar nerve. The NM-345Y is placed as d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 18 years old or older Surgery: Laparoscopic surgery in the 0 degrees pronation position of both upper limbs Diseases: Upper gastrointestinal, lower gastrointestinal, hepatobiliary, gynecologic, or urologic diseases

Exclusion criteria

Exclusion criteria: Patients who already have neurological disorders (e.g., paralysis) Patients with neuromuscular diseases Patients with pacemakers or implantable cardioverter defibrillators Pregnant women Patients with fragile skin where the electromyography electrode seal is attached Patients with a history of surgery on the measuring limb Patients with a history of allergy to rocuronium or sugammadex Patients undergoing hemodialysis Patients undergoing robot-assisted laparoscopic surgery

Design outcomes

Primary

Measure	Time frame
Time to the appearance of the first post-tetanic count (PTC) after the first rocuronium administration	—

Secondary

Measure	Time frame
The stimulus current value and sensitivity at calibration, time to the appearance of the first train-of-four (TOF) count after the first rocuronium administration, total PTC counts every two hours after positional change, time to the appearance of the TOF counts one, two, three, and four after the last rocuronium administration, the TOF counts or the TOF ratio and the amplitudes of T1 before and after sugammadex administration, time to the TOF ratio greater than 0.9 after sugammadex administration	—

Measure

Time frame

The stimulus current value and sensitivity at calibration, time to the appearance of the first train-of-four (TOF) count after the first rocuronium administration, total PTC counts every two hours after positional change, time to the appearance of the TOF counts one, two, three, and four after the last rocuronium administration, the TOF counts or the TOF ratio and the amplitudes of T1 before and after sugammadex administration, time to the TOF ratio greater than 0.9 after sugammadex administration

—

Countries

Japan

Contacts

Public ContactShohei Kaneko

Nagasaki University Hospital Department of Anesthesiology

s-kaneko@nagasaki-u.ac.jp095-819-7370

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026