Comparison of IONM Between Remimazolam and Propofol

Cervical Spondylotic Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968054
• Other study ID #: 3-2021-0189
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: October 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spondylotic Myelopathy
• Spinal Cord Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)