A Randomized, Double-Blind, Comparative Trial of Stimulation Electrode Placement during Electromyography-based Neuromuscular Monitoring (Pilot Study)

A Randomized, Double-Blind, Comparative Trial of Stimulation Electrode Placement during Electromyography-based Neuromuscular Monitoring (Pilot Study) - A Randomized, Double-Blind, Comparative Trial of Stimulation Electrode Placement during Electromyography-based Neuromuscular Monitoring (Pilot Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051981

Enrollment

Registered

2023-08-29

Start date

2023-08-30

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 ulnar nerve crosses the line connecting the centers of the anode and cathode of the stimulating electrodes. The NM-345Y is placed as

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 applied 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 2 hours after positional change, time to the appearance of the TOF counts 1, 2, 3, and 4 after the last rocuronium administration, the TOF counts or the TOF ratio and the amplitudes of T1, T2, T3, and T4 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 2 hours after positional change, time to the appearance of the TOF counts 1, 2, 3, and 4 after the last rocuronium administration, the TOF counts or the TOF ratio and the amplitudes of T1, T2, T3, and T4 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