Effect of Remimazolam on Motor Evoked Potential

Spine Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453955
• Other study ID #: 2022GR0051
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: March 2023
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 7, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Diseases
• Spine Disease

Intervention

Drug:
• Propofol
Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam
• Remimazolam Besylate
Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol

Locations

Country	Name	City	State
Korea, Republic of	Seok Kyeong Oh	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Bispectral index	Bispectral index during MEP data collection	Intraoperative
Secondary	Blood pressure	Blood pressure during MEP data collection	Intraoperative
Secondary	Heart rate	Heart rate during MEP data collection	Intraoperative