Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05453955
Other study ID # 2022GR0051
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06006377 - Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies N/A
Active, not recruiting NCT04379921 - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch N/A
Completed NCT04956588 - Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery Phase 3
Completed NCT04834141 - Correlation Between Thoracic Kyphosis Posture and Static Balance
Completed NCT04691258 - Back Squat Exercise Treatment for Low Back Pain: Clinical Trial N/A
Recruiting NCT06400680 - Gait Spine Functional Evaluation Protocol N/A
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Not yet recruiting NCT06393530 - Erector Spinae Plane Block for Cervical Spine Surgery Phase 4
Recruiting NCT04825522 - The Effect of Intrawound Vancomycin Powder in Spine Surgery Phase 4
Recruiting NCT05889611 - Iterative Endotracheal Tube Cuff Pressure Monitoring
Completed NCT03079076 - Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery Phase 4
Recruiting NCT06233617 - Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery Phase 4
Recruiting NCT05589402 - Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI Phase 1
Completed NCT03214536 - Erector Spine Block for Back Surgery N/A
Recruiting NCT06462729 - LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) Phase 1/Phase 2
Not yet recruiting NCT06059599 - Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals N/A
Completed NCT05166018 - Optimization of a Tool for Predicting Postoperative Clinical Evolution After Lumbar Surgery N/A
Not yet recruiting NCT03848377 - EMG and SSEP Device (EPAD® 2.0) for Intraoperative Monitoring of Patient Undergoing Spinal Nerve Spine Surgery
Active, not recruiting NCT04227717 - Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine
Completed NCT03417193 - Opioid Free Anesthesia and Major Spine Surgery N/A