Effect of Remimazolam Versus Propofol on Motor Evoked Potentials and Somatosensory Evoked Potentials During Spinal Tumor Surgery: A Randomized Controlled Trial
Sponsor study identifier
interventional
190
1 country
1
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2026
Actual (reported)October 28, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
MEP amplitude preservation ratio during the critical period of tumor manipulation
Mean motor evoked potential (MEP) amplitude of the target muscles recorded during the critical period of tumor manipulation (time points T2 to T4), expressed as a percentage of the baseline (T0) amplitude. Baseline MEP amplitude is recorded after induction of anesthesia and before surgical incision, with a train-of-four ratio of at least 0.9. The primary analysis uses analysis of covariance with adjustment for baseline MEP amplitude, tumor type, tumor level, age and body mass index, under the intention-to-treat principle, with a per-protocol sensitivity analysis. The superiority margin is zero.
Intraoperative: from the baseline recording (after induction of anesthesia and before surgical incision) through the end of tumor manipulation
Incidence of intraoperative neurophysiological monitoring alert events
Intraoperative: from the baseline recording after induction of anesthesia to the end of surgery
Remimazolam is administered for induction of anesthesia at 0.2-0.3 mg/kg intravenously and for maintenance by continuous infusion at 1-2 mg/kg/h, titrated to a bispectral index of 40-60. Depth of anesthesia, analgesia and neuromuscular blockade are standardized identically in both arms: sufentanil 0.3-0.5 micrograms/kg at induction, remifentanil 0.08-0.15 micrograms/kg/min for maintenance, and a single dose of rocuronium 0.6 mg/kg at induction with no intraoperative top-up. Core temperature is maintained at 36.0-37.5 degrees Celsius, mean arterial pressure within 10 percent of baseline and not below 80 mmHg, and heart rate between 50 and 100 beats per minute.
Propofol is administered for induction of anesthesia at 1.5-2.5 mg/kg intravenously and for maintenance by continuous infusion at 4-6 mg/kg/h, titrated to a bispectral index of 40-60. Depth of anesthesia, analgesia and neuromuscular blockade are standardized identically in both arms: sufentanil 0.3-0.5 micrograms/kg at induction, remifentanil 0.08-0.15 micrograms/kg/min for maintenance, and a single dose of rocuronium 0.6 mg/kg at induction with no intraoperative top-up. Core temperature is maintained at 36.0-37.5 degrees Celsius, mean arterial pressure within 10 percent of baseline and not below 80 mmHg, and heart rate between 50 and 100 beats per minute.
Intravenous remimazolam administered for induction of general anesthesia at 0.2-0.3 mg/kg and maintained by continuous infusion at 1-2 mg/kg/h, titrated to a bispectral index of 40-60 throughout surgery.
Intravenous propofol administered for induction of general anesthesia at 1.5-2.5 mg/kg and maintained by continuous infusion at 4-6 mg/kg/h, titrated to a bispectral index of 40-60 throughout surgery.
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218, China
Cui J, Zhou B, Wang J, Yao L. Effect of intravenous infusion of remimazolam versus propofol on intraoperative neurophysiological monitoring stability and postoperative neurological function in patients undergoing spinal surgery. Am J Transl Res. 2026 Apr 15;18(4):3309-3321. doi: 10.62347/QLLI7857. eCollection 2026.
Kim BR, Kim HB, Kim MS, Lim BG, Oh SK. Influence of Remimazolam and Propofol on Intraoperative Motor Evoked Potentials During Spinal Surgery: A Randomized Crossover Trial. J Clin Med. 2025 Aug 4;14(15):5491. doi: 10.3390/jcm14155491.
First Submitted
October 21, 2026
First Posted
October 28, 2026
Change in somatosensory evoked potential N20 or P37 latency and amplitude
Intraoperative: from the baseline recording after induction of anesthesia to the end of surgery
Rate of change and variability of motor evoked potential amplitude
Intraoperative: from the baseline recording after induction of anesthesia to the end of surgery
Intraoperative hemodynamic variables and vasoactive drug requirement
Intraoperative: from induction of anesthesia to the end of surgery
Time to extubation and post-anesthesia care unit length of stay
From the end of surgery to discharge from the post-anesthesia care unit, up to 24 hours
Contact the study team to confirm eligibility.
Kim MH, Park J, Park YG, Cho YE, Kim D, Lee DJ, Kwak KW, Lee J, Han DW. Comparison of intraoperative neurophysiological monitoring between propofol and remimazolam during total intravenous anesthesia in the cervical spine surgery: a prospective, double-blind, randomized controlled trial. Korean J Anesthesiol. 2025 Feb;78(1):16-29. doi: 10.4097/kja.24613. Epub 2024 Nov 12.
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
De-identified individual participant data that underlie the results reported in the primary publication will be shared, together with the study protocol, statistical analysis plan and informed consent form. Data will be available for researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: