Effect of Remimazolam on Motor Evoked Potential
Influence of Propofol and Remimazolam on Intraoperative Responses of Motor Evoked Potentials During Spine Surgery
1 other identifier
interventional
20
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedMarch 15, 2023
March 1, 2023
6 months
July 8, 2022
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Motor evoked potential (MEP), before cross-over
Amplitude and latency of MEP before cross-over
Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes
MEP, after cross-over
Amplitude and latency of MEP after cross-over
Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes
Secondary Outcomes (3)
Bispectral index
Intraoperative
Blood pressure
Intraoperative
Heart rate
Intraoperative
Study Arms (2)
Propofol-Remimazolam
EXPERIMENTALGeneral anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.
Remimazolam-Propofol
EXPERIMENTALGeneral anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.
Interventions
Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam
Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol
Eligibility Criteria
You may qualify if:
- Aged 20-70
- Scheduled for elective spine surgery requiring monitoring of evoked potential
- ASA physical status 1-3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seok Kyeong Oh
Seoul, Gangnam-gu, 06294, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Sik Choi, MD, PhD
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 8, 2022
First Posted
July 12, 2022
Study Start
August 1, 2022
Primary Completion
February 2, 2023
Study Completion
February 7, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share