A study on novel lower cranial nerve monitoring during neurosurgery

JRCT ID: jRCT1052240064

Registered date:13/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Brain tumors, cerebrovascular disorders,spinal diseases, facial spasm, trigeminal neuralgia
• Date of first enrollment: 01/07/2024
• Target sample size: 30
• Study type: Observational

Outcome(s)

Primary Outcome

Detection rate/amplitude in monitoring using a conventional intubation tube
Detection rate/amplitude in monitoring using a gastric tube with electromyogram
Comparison of accuracy rates between lower cranial nerve monitoring using a conventional intubation tube and monitoring using a gastric tube with electromyogram.

Secondary Outcome

Threshold in transcranial MEP
Changes in intraoperative MEP
New appearance or worsening of postoperative dysphagia
Comparison of complication rates between lower cranial nerve monitoring using a conventional intubation tube and gastric tube monitoring with electromyography (allergies, burns, oral mucosal damage)

Key inclusion & exclusion criteria

• Age minimum: >= 19age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who will undergo craniotomy involving the lower cranial nerves and will undergo intraoperative monitoring using a gastric tube with an electromyogram between the time of research permission and December 2030.
2. Male and female patients aged 18 years or older who have given written consent.

Exclude criteria

1. Patients who have withdrawn consent for this study
2. Research subjects who have allergies to the metal or adhesive contained in the electrodes

Related Information

• Primary Sponsor: Morisaki Yudai
• Source(s) of Monetary Support: Japan society for the promotion of science Young Researchers (subject number 24K21144)