Comparison of IONM Between Remimazolam and Propofol

Not Applicable

Completed

• Conditions: Ossification Posterior Longitudinal Ligament; Cervical Spondylotic Myelopathy
• Interventions: Drug: Arm II (Remimazolam); Drug: Arm I (Propofol)

• Registration Number: NCT04968054
• Lead Sponsor: Gangnam Severance Hospital

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 available

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-13
• Study Start: 2021-07-20
• Study First Posted: 2021-07-20
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Arm II (Remimazolam)	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.
Propofol group	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

Primary Outcome Measures

Name	Time	Method
Latency of SSEPs	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

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of