Study on the effects of remimazolam on motor evoked potentials in pediatric patients undergoing spine/spinal cord surgery

JRCT ID: jRCTs041230165

Registered date:06/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Spine/spinal cord disease
• Date of first enrollment: 06/03/2024
• Target sample size: 62
• Study type: Interventional
• Intervention(s): The motor evoked potentials are measured after changing from general anesthesia using propofol to general anesthesia using remimazolam.

Outcome(s)

• Primary Outcome: Percentage of cases in which surgery was started with remimazolam anesthesia after confirming that the MEP of the trapezius muscle in cervical spine cases, and the deltoid muscle and abductor digiti minimi muscle in thoracolumbar spine cases, did not decrease in amplitude under remimazolam anesthesia by more than 70% of the amplitude under propofol anesthesia.

Secondary Outcome

Percentage of cases in which surgery could be completed with remimazolam anesthesia
MEP derivation, amplitude, and latency for each muscle in the first MEP measurement after the introduction of propofol and remimazolam
Anesthesia induction time
Time from completion of surgery to extubation
Time from completion of surgery to leaving the room
Difference in cost of drugs used
Adverse event
Incidence rate of postoperative paralysis
Changes in MEP derivation, amplitude, and latency from the start of surgery to the end of surgery
Percentage of MEP recovery cases after restarting propofol

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 18age old
• Gender: Both
• Include criteria: Patients aged 6 months or older and younger than 18 years who will undergo surgery under general anesthesia and whose motor evoked potentials will be measured during surgery.

Exclude criteria

Age 18 years or older
Patients who are assumed to be allergic to propofol
Patients whose baseline MEP could not be measured with propofol
Case where it is considered difficult to continue the research based on the judgment of the attending department and anesthesiology department
Patients who are judged to be unsuitable for participation in this study by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Tamura Takahiro