Effect of Remimazolam on Motor Evoked Potential

NCT ID: NCT05453955

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-02-07

Brief Summary

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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

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Conditions

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Spine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Propofol-Remimazolam

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remimazolam Besylate

Intervention Type DRUG

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

Remimazolam-Propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remimazolam Besylate

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Remimazolam Besylate

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

Intervention Type DRUG

Other Intervention Names

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Remimazolam Besylate Propofol

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seok Kyeong Oh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Sik Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Seok Kyeong Oh

Seoul, Gangnam-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2022GR0051

Identifier Type: -

Identifier Source: org_study_id

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