Trial · NCT07880548
Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
NCT07880548, Phase 3, Not yet recruiting, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients. Trials, record NCT07880548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
- NCT number
- NCT07880548
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 274 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
- Interventions
- Remimazolam group, Propofol group
- First posted
- 2026-10-19
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to successful extubation | From randomization to 28 days after randomization | Successful extubation defined as: (a) intubated patients - spontaneous breathing within 48 h after extubation without need for mechanical ventilatory support; (b) non-invasive ventilation patients - spontaneous breathing with PEEP/CPAP ≤ 5 cmH2O within 48 h; (c) tracheostomized patients - spontaneous breathing with PEEP/CPAP ≤ 5 cmH2O within 48 h. |
| Secondary | Change from baseline to daily mean arterial pressure (MAP) | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Change from baseline to daily mean arterial pressure (MAP) within the 7 days (or successful extubation) after randomization. Mean arterial pressure (MAP) was monitored hourly, and the daily MAP value was computed as the mean of all 24 hourly measurements. |
| Secondary | Change from baseline to daily vasoactive-inotropic score | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Change from baseline to daily vasoactive-inotropic score within the 7 days (or successful extubation) after randomization |
| Secondary | Change from baseline to follow-up in total cholesterol and triglycerides | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | total cholesterol and triglycerides are measured at the screening period (baseline) and every 7 days after randomization |
| Secondary | Change from baseline to daily SOFA-2 score | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Difference between mean daily SOFA-2 score within 7 days after randomization (or successful extubation, whichever comes first) and the baseline SOFA-2 score. |
| Secondary | Time from study drug administration to first achievement of optimal sedation | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Time from randomization to first achievement of optimal sedation (optimal sedation defined based on the SQAT) |
| Secondary | The proportion of rescue sedation | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | The proportion of subjects receiving rescue sedation in each group during 0-24 h, 0-48 h, 0-72 h, 0-96 h, 0-120 h, or the treatment period |
| Secondary | The proportion of delirium | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Incidence and duration of delirium druing study period (CAM-ICU was assessed every 12 h after randomization during ICU) |
| Secondary | Vasopressor-free days within 28-day after randomizaiton | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | |
| Secondary | The length of ICU stay | From randomization to ICU discharge ( up to 28 days after randomization) | Days randomization to ICU discharge |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers2
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/NCT07880548
GET https://conductscience.org/api/trials/v1/NCT07880548/registered