Spine Disease
Conditions
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).
Interventions
DRUGPropofol
Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam
DRUGRemimazolam Besylate
Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor evoked potential (MEP), before cross-over | Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes | Amplitude and latency of MEP before cross-over |
| MEP, after cross-over | Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes | Amplitude and latency of MEP after cross-over |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bispectral index | Intraoperative | Bispectral index during MEP data collection |
| Blood pressure | Intraoperative | Blood pressure during MEP data collection |
| Heart rate | Intraoperative | Heart rate during MEP data collection |
Countries
South Korea
Outcome results
None listed