Trial · NCT07901504
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
NCT07901504, Phase 4, Not yet recruiting, Beijing Tsinghua Chang Gung Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery. Trials, record NCT07901504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
- NCT number
- NCT07901504
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 190 participants, estimated
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Conditions
- Spinal Cord Neoplasms, Spinal Neoplasms
- Interventions
- Remimazolam, Propofol
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Incidence of intraoperative neurophysiological monitoring alert events | Intraoperative: from the baseline recording after induction of anesthesia to the end of surgery | Proportion of participants with at least one intraoperative neurophysiological monitoring alert event, defined as a decrease in MEP amplitude of 50 percent or more from baseline, or prolongation of somatosensory evoked potential latency of 10 percent or more from baseline. |
| Secondary | 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 | Change from baseline in the latency and amplitude of the cortical somatosensory evoked potential component (N20 for upper-limb stimulation or P37 for lower-limb stimulation), expressed as a percentage of the baseline value. |
| Secondary | Rate of change and variability of motor evoked potential amplitude | Intraoperative: from the baseline recording after induction of anesthesia to the end of surgery | Absolute and percentage change in MEP amplitude from baseline at each intraoperative time point, and the coefficient of variation of MEP amplitude across the monitoring period. |
| Secondary | Intraoperative hemodynamic variables and vasoactive drug requirement | Intraoperative: from induction of anesthesia to the end of surgery | Mean arterial pressure, heart rate, and cumulative dose of vasoactive agents required to maintain mean arterial pressure within 10 percent of baseline and not below 80 mmHg. |
| Secondary | 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 | Time from discontinuation of the anesthetic infusion to tracheal extubation, and duration of stay in the post-anesthesia care unit. |
| Secondary | Quality of recovery assessed by the Quality of Recovery-15 questionnaire | Postoperative day 1 and postoperative day 2 | Total score of the Quality of Recovery-15 (QoR-15) questionnaire, ranging from 0 to 150, with higher scores indicating better quality of recovery. |
| Secondary | Neurological function assessed by the Japanese Orthopaedic Association score | Before surgery, postoperative day 1, and postoperative day 30 | Japanese Orthopaedic Association (JOA) score assessed before surgery and after surgery; lower scores indicate greater neurological impairment. The change from baseline and its correlation with intraoperative MEP variability are evaluated. |
| Secondary | Incidence of adverse events and serious adverse events | From induction of anesthesia through postoperative day 30 | Number and proportion of participants experiencing treatment-emergent adverse events and serious adverse events, coded by preferred term and system organ class. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07901504
GET https://conductscience.org/api/trials/v1/NCT07901504/registered