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

UMIN ID: UMIN000053918

Registered date:20/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with upper gastrointestinal, lower gastrointestinal, hepatobiliary, gynecologic, or urologic diseases undergoing laparoscopic surgery in the 0 degrees pronation in both upper limb position
• Date of first enrollment: 2024/04/22
• Target sample size: 44
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 described in the AF-201P Instruction Manual by Nihon-Kohden (revised June 6, 2022).
The NM-345Y is placed as described in the AF-201P Instruction Manual by Nihon-Kohden (revised January, 2023).

Outcome(s)

• Primary Outcome: Time to the appearance of the first post-tetanic count (PTC) after the first rocuronium administration
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Nagasaki University Hospital
• Source(s) of Monetary Support: Nagasaki University Hospital