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CompletedNCT05453955Updated Mar 15, 2023

Effect of Remimazolam on Motor Evoked Potential

An interventional study of Propofol and Remimazolam Besylate in Spine Disease, sponsored by Korea University Guro Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Korea University Guro Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

This study was planned to investigate the degree of effect of remimazolam on MEP compared to propofol when monitoring the motion-inducing potential (MEP).

02

Conditions studied

  • Spine Disease

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03

In context

Spinal Diseases

268 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 20 is below the median of 52 across 167 interventional studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 20-70
  • Scheduled for elective spine surgery requiring monitoring of evoked potential
  • ASA physical status 1-3

Exclusion criteria

Exclusion Criteria:

  • BMI ≥ 40
  • Uncontrolled DM (HbA1c ≥ 9%)
  • Contraindications to the study drug: known allergy or hypersensitivity
  • Use of rate responsive cardiac pacemaker with bioelectrical impedence
  • Diagnosed neuromuscular disorder
  • Pre-existing motor weakness
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Propofol-Remimazolam

    General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.

    Drug: Propofol · Drug: Remimazolam Besylate

  • Experimental
    Remimazolam-Propofol

    General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.

    Drug: Propofol · Drug: Remimazolam Besylate

Interventions

  • DrugPropofol

    Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam

    Also known as: Remimazolam Besylate

  • DrugRemimazolam Besylate

    Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol

    Also known as: Propofol

06

What researchers measure

Primary outcomes

  1. Motor evoked potential (MEP), before cross-over

    Amplitude and latency of MEP before cross-over

    Time frame: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes

  2. MEP, after cross-over

    Amplitude and latency of MEP after cross-over

    Time frame: Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes

Secondary outcomes

  1. Bispectral index

    Bispectral index during MEP data collection

    Time frame: Intraoperative

  2. Blood pressure

    Blood pressure during MEP data collection

    Time frame: Intraoperative

  3. Heart rate

    Heart rate during MEP data collection

    Time frame: Intraoperative

07

Study locations

1 site
  • Seok Kyeong Oh
    Seoul, Gangnam-gu 06294, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05453955
Lead sponsor
Korea University Guro Hospital
Responsible party
Seok Kyeong Oh (Assistant Professor, Korea University Guro Hospital) — Principal investigator
First posted
Jul 12, 2022
Start date
Aug 1, 2022
Primary completion
Feb 2, 2023
Completion
Feb 7, 2023
Last update
Mar 15, 2023

Study contacts

Sang Sik Choi, MD, PhD
principal investigator · Korea University Guro Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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