Clinical Research Directory

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

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.

Intradurale Spinal Tumors: Management and Treatment

Intradurale spinal tumors are rare neoplastic lesions that involve the spinal cord and surrounding structures and may cause neurological symptoms such as pain, motor deficits, sensory disturbances, and sphincter dysfunction. Surgical resection is often the primary treatment when feasible and may improve neurological outcomes and relieve spinal cord compression. This retrospective observational study aims to analyze the epidemiological and clinical characteristics of patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024. Clinical, radiological, and pathological data will be collected from electronic medical records, operative reports, and diagnostic imaging. The study will evaluate preoperative and postoperative neurological status using the McCormick functional scale, as well as postoperative complications and tumor recurrence. The results of this study may contribute to improving the understanding of the clinical management of intradural spinal tumors and identifying factors associated with surgical outcomes and patient prognosis.

Microsurgical Resection of Intramedullary Spinal Cord Metastases

The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients. The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively. Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients. The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment. Primary endpoint (analysed in surgically treated ISCM patients): Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability. Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment): * Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy. * Ambulatory status and continence at 90 days, 6 \& 12 months (determined by mJOA subscores) * Neurological outcome, measured by American Spinal Cord Injury Association (ASIA) * Impairment Scale at 90 days, 6 and 12 months * Rate \& type of complications at 90 days after treatment according to The Novel Therapy * Disability-Neurology Grade (TDN grade)16 * Overall survival (in days)