Clinical Trial

Ciprofol and Remimazolam for Intraoperative Neurophysiological Monitoring During Spine Surgery

Study acronym: CIRIONM
Not Yet Recruiting Phase 4
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Summary
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.
Trial Details
NCT Number NCT07718152
Lead Sponsor Affiliated 2 Hospital of Nantong University
Conditions Intraoperative Neurophysiological Monitoring, Spine Surgery, Anesthesia
Enrollment 60 participants
Start Date 2026-08
Primary Completion 2026-12 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-21