Intraoperative Neurophysiological Monitoring

Intraoperative neurophysiological monitoring, including motor evoked potentials and somatosensory evoked potentials, is commonly used during spine surgery to help detect impending neurological injury. The quality of these signals can be affected by anesthetic agents. Ciprofol and remimazolam are newer intravenous hypnotic agents that may be suitable for total intravenous anesthesia during procedures requiring neurophysiological monitoring, but direct within-patient comparisons between the two agents are lacking. This single-center, prospective, randomized, two-sequence crossover trial will compare the effects of ciprofol and remimazolam, administered with remifentanil, on intraoperative MEP and SEP signal quality during spine surgery. Eligible participants will be randomized to receive either ciprofol followed by remimazolam or remimazolam followed by ciprofol during predefined stable intraoperative monitoring windows. The primary outcome is the within-participant difference in lower-extremity MEP peak-to-peak amplitude between the ciprofol and remimazolam periods. Secondary outcomes include SEP amplitude and latency, MEP latency, warning-threshold events, hemodynamic variables, rescue medication requirements, recovery characteristics, and postoperative neurological status.

This randomized controlled trial will compare two strategies for rocuronium use during general anesthesia for spine surgery with intraoperative neurophysiological monitoring. Participants undergoing spine surgery under general anesthesia with motor evoked potential and/or somatosensory evoked potential monitoring will be randomized to either low-dose rocuronium maintenance targeting a train-of-four ratio of 0.60 to less than 0.90, or no rocuronium maintenance after induction. The main objective is to compare the effects of these two strategies on the quality of intraoperative neurophysiological monitoring, especially motor evoked potential signals. Secondary objectives include comparing surgical field conditions, unwanted patient movement, emergence and extubation times, early respiratory events, and new postoperative neurological deficits. The study will be conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam. The planned sample size is 62 participants, with 31 participants in each group.

Magnesium Sulfate(MgSo4) is increasingly being used as part of the multimodal pain regimen in the perioperative period. The intraoperative neurophysiological monitoring (IONM) is utilized in complex spine and cranial surgeries to assess the functional integrity of the neural pathways. The effect of Magnesium sulfate on IONM has not been studied. This is a prospective, double blind, randomized placebo controlled trial to study the effect of Magnesium sulfate bolus on the amplitude and latency of somatosensory(SSEPs) and motor evoked potentials(MEPs) in patients undergoing surgery requiring IONM.

This clinical investigation is a pilot, first-in-human (FIH) study designed to demonstrate proof of concept, safety, and functional performance of the MINDZ subdural electrode grid when used in relevant neurosurgical settings. The study will provide initial clinical evidence to support future conformity assessment and CE marking under the European Medical Device Regulation (MDR). The investigational device, MINDZ, developed by Neurosoft Bioelectronics, is a novel, soft and highly conformable subdural electrode grid designed for minimally invasive implantation through a burr hole. Its flexible structure is intended to improve conformity to the cortical surface, reduce dead space between the electrode and brain tissue, and potentially lower the risk of complications associated with craniotomy, while maintaining adequate cortical coverage for effective monitoring and mapping.