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Clinical Trials in China / NCT07901504
Starting soon Phase 4

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

NCT07901504 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tsinghua Chang Gung Hospital
Phase
Phase 4
Started
2027-01
Last updated
2026-10-28

Condition(s) studied

Spinal Cord NeoplasmsSpinal Neoplasms

Investigational drug(s) / intervention(s)

Remimazolam →Propofol →

Remimazolam: 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.

Propofol: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older * American Society of Anesthesiologists physical status I to III * Scheduled for elective resection of a spinal tumor * Clinical indication for intraoperative neurophysiological monitoring, with agreement to combined motor evoked potential and somatosensory evoked potential monitoring * Written informed consent provided by the participant or the legally authorized representative Exclusion Criteria: * Failure to obtain reproducible baseline motor evoked potential or somatosensory evoked potential waveforms before surgical incision * Known allergy or contraindication to remimazolam, propofol, sufentanil, remifentanil or rocuronium * Chronic use of sedatives, analgesics or antiepileptic drugs, or a history of drug abuse * Severe cardiac, hepatic, pulmonary or renal dysfunction, coagulopathy, intracranial pathology, or a history of epilepsy * Severe spinal deformity or severe spinal canal stenosis that precludes safe surgery or reliable monitoring * Pregnancy or lactation * Participation in another interventional clinical trial within the previous 3 months * Any other condition judged by the investigator to make participation unsuitable

Primary outcome measure(s)

  • MEP amplitude preservation ratio during the critical period of tumor manipulation — Intraoperative: from the baseline recording (after induction of anesthesia and before surgical incision) through the end 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.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tsinghua Chang Gung Hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901504 on ClinicalTrials.gov ↗ ← All trials in China