Effect of Remimazolam on Motor Evoked Potential

March 13, 2023 updated by: Seok Kyeong Oh, Korea University Guro Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06294
        • Seok Kyeong Oh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor evoked potential (MEP), before cross-over
Time Frame: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes
Amplitude and latency of MEP before cross-over
Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes
MEP, after cross-over
Time Frame: Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes
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
Time Frame: Intraoperative
Bispectral index during MEP data collection
Intraoperative
Blood pressure
Time Frame: Intraoperative
Blood pressure during MEP data collection
Intraoperative
Heart rate
Time Frame: Intraoperative
Heart rate during MEP data collection
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Investigators

  • Principal Investigator: Sang Sik Choi, MD, PhD, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022GR0051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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