Back to results

Effect of Remimazolam on Motor Evoked Potential

Primary Purpose

Spine Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Propofol

Remimazolam Besylate

About this trial

This is an interventional other trial for Spine Disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seok Kyeong Oh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Propofol-Remimazolam

Remimazolam-Propofol

Arm Description

General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.

General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.

Outcomes

Primary Outcome Measures

Motor evoked potential (MEP), before cross-over

Amplitude and latency of MEP before cross-over

MEP, after cross-over

Amplitude and latency of MEP after cross-over

Secondary Outcome Measures

Bispectral index

Bispectral index during MEP data collection

Blood pressure

Blood pressure during MEP data collection

Heart rate

Heart rate during MEP data collection

Full Information

NCT ID

NCT05453955

First Posted

July 8, 2022

Last Updated

March 13, 2023

Sponsor

Korea University Guro Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05453955

Brief Title

Effect of Remimazolam on Motor Evoked Potential

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

February 2, 2023 (Actual)

Study Completion Date

February 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spine Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propofol-Remimazolam

Arm Type

Experimental

Arm Description

General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.

Arm Title

Remimazolam-Propofol

Arm Type

Experimental

Arm Description

General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

Remimazolam Besylate

Intervention Description

Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam

Intervention Type

Drug

Intervention Name(s)

Remimazolam Besylate

Other Intervention Name(s)

Propofol

Intervention Description

Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol

Primary Outcome Measure Information:

Title

Motor evoked potential (MEP), before cross-over

Description

Amplitude and latency of MEP before cross-over

Time Frame

Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes

Title

MEP, after cross-over

Description

Amplitude and latency of MEP after cross-over

Time Frame

Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes

Secondary Outcome Measure Information:

Title

Bispectral index

Description

Bispectral index during MEP data collection

Time Frame

Intraoperative

Title

Blood pressure

Description

Blood pressure during MEP data collection

Time Frame

Intraoperative

Title

Heart rate

Description

Heart rate during MEP data collection

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Sik Choi, MD, PhD

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seok Kyeong Oh

City

Seoul

State/Province

Gangnam-gu

ZIP/Postal Code

06294

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Remimazolam on Motor Evoked Potential

We'll reach out to this number within 24 hrs