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Completed

NCT Number: NCT05453955

Effect of Remimazolam on Motor Evoked Potential

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

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Key information

Conditions

Spine Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seok Kyeong Oh

Seoul, Gangnam-gu, 06294, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Other names: Remimazolam Besylate

Remimazolam besylate

Drug

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

Other names: Propofol

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Bispectral index

    Time frame: Intraoperative

    Bispectral index during MEP data collection

  2. Blood pressure

    Time frame: Intraoperative

    Blood pressure during MEP data collection

  3. Heart rate

    Time frame: Intraoperative

    Heart rate during MEP data collection

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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