Effect of Remimazolam on Motor Evoked Potential

Not Applicable

Completed

• Conditions: Spine Disease
• Interventions: Drug: Propofol; Drug: Remimazolam Besylate

• Registration Number: NCT05453955
• Lead Sponsor: Korea University Guro Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Study Start: 2022-08-01
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-07
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Remimazolam-Propofol	Propofol	General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.
Propofol-Remimazolam	Remimazolam Besylate	General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.
Remimazolam-Propofol	Remimazolam Besylate	General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.
Propofol-Remimazolam	Propofol	General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bispectral index	Intraoperative	Bispectral index during MEP data collection
Heart rate	Intraoperative	Heart rate during MEP data collection
Blood pressure	Intraoperative	Blood pressure during MEP data collection

Trial Locations

Locations (1)

Seok Kyeong Oh; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of