JRCT ID: jRCT1012250055
Registered date:25/12/2025
A Comparative Study of Stimulation Modes (Constant Current and Constant Voltage) in Motor Evoked Potential Monitoring During Orthopedic Surgery
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Spinal Diseases |
| Date of first enrollment | 25/12/2025 |
| Target sample size | 66 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Neuromuscular blockade is reversed to achieve a TOF count of 4 and a TOF ratio of 100%. Stimulation settings are as follows. Monophasic waveform, pulse width of 0.5 ms, interstimulus interval of 2.0 to 4.0 ms, and a train of 4 to 6 pulses.Stimulation intensity is set at 1 to 200 mA for constant current mode and 1 to 500 V for constant voltage mode. A amplitude of 20 to 50 microV or greater is defined as the stimulation threshold. To avoid threshold bias caused by the Wedensky effect, a crossover design is employed in which the order of constant current and constant voltage stimulation is alternated between patients. |
Outcome(s)
| Primary Outcome | Difference in stimulation thresholds of the abductor pollicis brevis (APB) during MEP monitoring Difference in stimulation thresholds of the abductor hallucis (AH) during MEP monitoring |
|---|---|
| Secondary Outcome | Amplitude of APB and AH MEPs at an effective current of 200 mA Electrode impedance MEP acquisition rate Depth of anesthesia (BIS value) |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Target patients: Individuals undergoing orthopedic surgery under general anesthesia with TES-MEP monitoring Target age: 20 years or older |
| Exclude criteria | Patients in whom appropriate MEP monitoring cannot be performed after electrode placement (e.g., insufficient muscle responses to electrical stimulation, poor reproducibility, etc.) Patients deemed unsuitable for participation in this study by the operating surgeon, attending anesthesiologist, principal investigator, or co-investigators |
Related Information
| Primary Sponsor | Emori Makoto |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Tomonori Morita |
| Address | 291, South 1, West 16, Chuo-ku, Sapporo-shi, Hokkaido, Japan. Hokkaido Japan 060-8543 |
| Telephone | +81-11-611-2111 |
| morita.tomonori@sapmed.ac.jp | |
| Affiliation | Sapporo Medical University School of Medicine Hospital |
| Scientific contact | |
| Name | Makoto Emori |
| Address | 291, South 1, West 16, Chuo-ku, Sapporo-shi, Hokkaido, Japan. Hokkaido Japan 060-8543 |
| Telephone | +81-11-611-2111 |
| memori@sapmed.ac.jp | |
| Affiliation | Sapporo Medical University School of Medicine Hospital |