Effect of Remimazolam on Motor Evoked Potential

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

Official Title
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Influence of Propofol and Remimazolam on Intraoperative Responses of Motor Evoked Potentials During Spine Surgery

Conditions
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Spine Disease

Intervention / Treatment
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* Drug: Propofol
* Drug: Remimazolam Besylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20-70 Scheduled for elective spine surgery requiring monitoring of evoked potential ASA physical status 1-3 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol-Remimazolam<br>General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision. | Drug: Propofol<br>* Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam<br>* Other names: Remimazolam Besylate;Drug: Remimazolam Besylate<br>* Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol<br>* Other names: Propofol;|
| Experimental: Remimazolam-Propofol<br>General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision. | Drug: Propofol<br>* Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam<br>* Other names: Remimazolam Besylate;Drug: Remimazolam Besylate<br>* Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol<br>* Other names: Propofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral index | Bispectral index during MEP data collection | Intraoperative | 
| Blood pressure | Blood pressure during MEP data collection | Intraoperative | 
| Heart rate | Heart rate during MEP data collection | Intraoperative |