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出境医 / 临床实验 / Comparison of IONM Between Remimazolam and Propofol

Comparison of IONM Between Remimazolam and Propofol

Study Description
Brief Summary:
Inhalation anesthetics significantly can delay latency and reduce amplitude of cortical MEPs and SSEPs signals compared to intravenous anesthetics by acting on not only GABA (γ-aminobutyric acid) receptors but also NMDA (N-methyl-D-aspartate) receptors, so total intravenous anesthesia (TIVA) have been more preferred for neurophysiological monitoring follow-up during surgery. However, just less than inhalation anesthetics, the decrease of amplitude and the delay of latency also occur according to the dose dependant of propofol. Moreover, it can cause various adverse effects such as delayed recovery after anesthesia or propofol infusion syndrome, consequently, combined methods with other agents or conversion to other relative anesthetics are being made. Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. Recently, there have been repored that continuous infusion of 0.5-1.5 mg/kg of remimazolam has little effect on the motor evoked potential (MEPs) of cervical spine surgery patients, but this is a case report without the control group; further prospective studies are definitely needed. Therefore, in the case of using propofol or remimazolam for total intravenous anesthesia, we aim to investigate which intravenous anesthetic is more appropriate for intraoperative neurophysiological monitoring by comparing the results of the somatosensory evoked potential (SSEPs) and MEPs according to these anesthetics.

Condition or disease Intervention/treatment Phase
Ossification Posterior Longitudinal Ligament Cervical Spondylotic Myelopathy Drug: Arm I (Propofol) Drug: Arm II (Remimazolam) Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Intraoperative Neurophysiological Monitoring According to the Use of Anesthetics During Total Intravenous Anesthesia in Spine Surgery Patients
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Propofol group
Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively
 Drug: Arm I (Propofol)
Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively.
Experimental: Remimazolam group
Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.
 Drug: Arm II (Remimazolam)
Remimazolam group started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.
Outcome Measures
Primary Outcome Measures :
  1. Latency of SSEPs [ Time Frame: At the 30 minutes after anesthetic induction (before surgical incision) ]
    The difference of SSEPs between the two groups (propofol vs. remimazolam) compared with baseline SSEPs


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients who aged 20-70 years with ASA-PS 1-3, diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy, in need of intraoperative neurophysiological monitoring

Exclusion Criteria:

  • Tolerance or hypersensitivity to benzodiazepine or propofol
  • Dependence or addiction to psychotropic drugs or alcohol
  • Previous brain-related neurosurgery
  • Inserted status of pacemaker
  • Inserted status of intracranial device
  • Steroids use during surgery
  • Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
GangnamSeverance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Woo Han    82-2-20194601    HANESTH@yuhs.ac   
Sponsors and Collaborators
Gangnam Severance Hospital
Tracking Information
First Submitted Date  ICMJE July 13, 2021
First Posted Date  ICMJE July 20, 2021
Last Update Posted Date August 26, 2021
Actual Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2021) 		Latency of SSEPs [ Time Frame: At the 30 minutes after anesthetic induction (before surgical incision) ]
The difference of SSEPs between the two groups (propofol vs. remimazolam) compared with baseline SSEPs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of IONM Between Remimazolam and Propofol
Official Title  ICMJE Comparison of Intraoperative Neurophysiological Monitoring According to the Use of Anesthetics During Total Intravenous Anesthesia in Spine Surgery Patients
Brief Summary Inhalation anesthetics significantly can delay latency and reduce amplitude of cortical MEPs and SSEPs signals compared to intravenous anesthetics by acting on not only GABA (γ-aminobutyric acid) receptors but also NMDA (N-methyl-D-aspartate) receptors, so total intravenous anesthesia (TIVA) have been more preferred for neurophysiological monitoring follow-up during surgery. However, just less than inhalation anesthetics, the decrease of amplitude and the delay of latency also occur according to the dose dependant of propofol. Moreover, it can cause various adverse effects such as delayed recovery after anesthesia or propofol infusion syndrome, consequently, combined methods with other agents or conversion to other relative anesthetics are being made. Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. Recently, there have been repored that continuous infusion of 0.5-1.5 mg/kg of remimazolam has little effect on the motor evoked potential (MEPs) of cervical spine surgery patients, but this is a case report without the control group; further prospective studies are definitely needed. Therefore, in the case of using propofol or remimazolam for total intravenous anesthesia, we aim to investigate which intravenous anesthetic is more appropriate for intraoperative neurophysiological monitoring by comparing the results of the somatosensory evoked potential (SSEPs) and MEPs according to these anesthetics.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Ossification Posterior Longitudinal Ligament
  • Cervical Spondylotic Myelopathy
Intervention  ICMJE
  • Drug: Arm I (Propofol)
    Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively.
  • Drug: Arm II (Remimazolam)
    Remimazolam group started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.
Study Arms  ICMJE
  • Active Comparator: Propofol group
    Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively
    Intervention: Drug: Arm I (Propofol)
  • Experimental: Remimazolam group
    Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.
    Intervention: Drug: Arm II (Remimazolam)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2021) 		66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients who aged 20-70 years with ASA-PS 1-3, diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy, in need of intraoperative neurophysiological monitoring

Exclusion Criteria:

  • Tolerance or hypersensitivity to benzodiazepine or propofol
  • Dependence or addiction to psychotropic drugs or alcohol
  • Previous brain-related neurosurgery
  • Inserted status of pacemaker
  • Inserted status of intracranial device
  • Steroids use during surgery
  • Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04968054
Other Study ID Numbers  ICMJE 3-2021-0189
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong Woo Han, Gangnam Severance Hospital
Study Sponsor  ICMJE Gangnam Severance Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gangnam Severance Hospital
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP