Clinical trial NCT04968054: Comparison of IONM Between Remimazolam and Propofol
Official title: Comparison of Intraoperative Neurophysiological Monitoring According to the Use of Anesthetics During Total Intravenous Anesthesia in Spine Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ossification Posterior Longitudinal Ligament
Cervical Spondylotic Myelopathy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Latency of SSEPs
timeFrame: At the 30 minutes after anesthetic induction (before surgical incision)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References: