Clinical Research Directory

Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery

Sponsor: Beijing Tsinghua Chang Gung Hospital

Summary

Intraoperative neurophysiological monitoring (IONM) using motor evoked potentials (MEP) and somatosensory evoked potentials (SEP) is routinely applied during spinal tumor resection to detect impending neurological injury. Propofol-based total intravenous anesthesia suppresses MEP amplitude in a dose-dependent manner, which can generate false-positive alerts and complicate interpretation of IONM signals. Remimazolam is an ultra-short-acting benzodiazepine whose effect on evoked potentials during spine surgery has not been well characterized. This prospective, single-center, randomized, parallel-group, superiority trial compares remimazolam-based versus propofol-based total intravenous anesthesia in adults undergoing elective spinal tumor resection with combined MEP and SEP monitoring. The primary hypothesis is that remimazolam better preserves MEP amplitude than propofol during the critical period of tumor manipulation. A total of 190 participants will be randomized 1:1. The primary outcome is the mean MEP amplitude of target muscles recorded during the critical period of tumor manipulation, expressed as a percentage of the pre-incision baseline value. The key secondary outcome is the incidence of intraoperative IONM alert events. Participants are followed for 30 days after surgery.

Official title: Effect of Remimazolam Versus Propofol on Motor Evoked Potentials and Somatosensory Evoked Potentials During Spinal Tumor Surgery: A Randomized Controlled Trial

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