Comparison of IONM Between Remimazolam and Propofol

Comparison of Intraoperative Neurophysiological Monitoring According to the Use of Anesthetics During Total Intravenous Anesthesia in Spine Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Cervical Spondylotic Myelopathy; Ossification Posterior Longitudinal Ligament
• Intervention / Treatment: Drug: Arm I (Propofol); Drug: Arm II (Remimazolam)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • GangnamSeverance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency of SSEPs	The difference of SSEPs between the two groups (propofol vs. remimazolam) compared with baseline SSEPs	At the 30 minutes after anesthetic induction (before surgical incision)

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 3-2021-0189

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No