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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041230165
Enrollment
62
Registered
2024-03-06
Start date
2024-03-06
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

Spine/spinal cord disease Spine/spinal cord disease

Interventions

The motor evoked potentials are measured after changing from general anesthesia using propofol to general anesthesia using remimazolam.

Sponsors

Kuwabara Takahiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactTakahiro Kuwabara

Nagoya University School of Medicine Hospital

kuwa0525bara@gmail.com+81-52-744-2340

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026