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Not yet recruitingNCT07880548RePro-ICUUpdated Oct 21, 2026

Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients

A Phase 3 interventional study of Remimazolam group and Propofol group in Long-term Sedation for Mechanical Ventilation and Critically Ill Intensive Care Unit Patients, sponsored by Sun Yat-sen University. Not yet recruiting at 21 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
274
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter, randomized, controlled, non-inferiority trial is designed to determine whether remimazolam is non-inferior to propofol for prolonged sedation in adult ICU patients requiring mechanical ventilation for ≥48 hours. A total of 274 patients will be enrolled across 21 geographically diverse hospitals in China and allocated in a 1:1 ratio to receive either remimazolam or propofol using centralized, computer-generated block randomization. The primary endpoint is time to successful extubation-defined as extubation without reintubation within 48 hours. Secondary endpoints include quantitative measures of sedation quality (e.g., RASS, time to target sedation), clinically outcomes (e.g., length of ICU stay, 28-day and 90-day all-cause mortality), and comprehensive safety evaluation (e.g., incidence and severity of hypotension, post-sedation delirium).

02

Conditions studied

  • Long-term Sedation for Mechanical Ventilation
  • Critically Ill Intensive Care Unit Patients

Keywords

  • Remimazolam tosilate
  • Propofol
  • Mechanical ventilation
  • ICU sedation
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years;
  2. The interval from ICU admission to the first receipt of mechanical ventilation is no more than 48 h, and the expected total duration of mechanical ventilation is ≥ 48 h;
  3. At the time of randomization, more than 24 h of further mechanical ventilation is anticipated;
  4. The attending clinician determines that sedation therapy is required;
  5. the subject and/or their legal guardian signs the informed consent form (ICF);
  6. Women and men of childbearing potential must agree to use highly effective contraception together with their partner and to refrain from donating oocytes or sperm from the time of ICF signing until 28 days after the last dose of study drug.

Exclusion criteria

Exclusion Criteria:

  1. History of hypersensitivity to benzodiazepines, propofol, remifentanil, or to any of their components or excipients;
  2. Severe neurological disease (e.g., myasthenia gravis, severe depression, schizophrenia, severe traumatic brain injury, massive cerebral infarction, status epilepticus, intracranial tumor, post-neurosurgical status);
  3. Post-cardiac arrest (with clinician-assessed hypoxic-ischemic brain injury);
  4. Subjects who require or are expected to require neuromuscular blocking agents after ICU admission;
  5. Pregnant or breastfeeding women;
  6. Life expectancy less than 24 hours;
  7. Receipt of palliative care;
  8. Hospice patients;
  9. Severe hepatic impairment (Child-Pugh class C);
  10. Participation in another clinical trial of an investigational drug with prior receipt of that drug;
  11. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
274 participants (estimated)

Study arms

  • Experimental
    Remimazolam group

    Drug: Remimazolam group

  • Active comparator
    Propofol group

    Drug: Propofol group

Interventions

  • DrugRemimazolam group

    Remimazolam tosilate injection by IV infusion: loading dose 0.05-0.10 mg/kg over ≥ 1 min, then maintenance starting at 0.2 mg/kg/h, titrated in 0.1-0.2 mg/kg/h to achieve the target depth of sedation RASS -2 to +1; maintenance range 0-2 mg/kg/h; up to 28 days of study drug treatment.

  • DrugPropofol group

    Propofol by IV infusion: loading dose 0.3-0.5 mg/kg over ≥ 1 min, then maintenance starting at 0.3 mg/kg/h, titrated in 0.3-0.6 mg/kg/h to achieve the target depth of sedation RASS -2 to +1; maintenance range 0-4 mg/kg/h; up to 28 days of study drug treatment.

    Also known as: Propofol medium/long-chain fat emulsion injection

06

What researchers measure

Primary outcomes

  1. Time to successful extubation

    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.

    Time frame: From randomization to 28 days after randomization

Secondary outcomes

  1. Change from baseline to daily mean arterial pressure (MAP)

    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.

    Time frame: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  2. Change from baseline to daily vasoactive-inotropic score

    Change from baseline to daily vasoactive-inotropic score within the 7 days (or successful extubation) after randomization

    Time frame: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  3. Change from baseline to follow-up in total cholesterol and triglycerides

    total cholesterol and triglycerides are measured at the screening period (baseline) and every 7 days after randomization

    Time frame: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  4. Change from baseline to daily SOFA-2 score

    Difference between mean daily SOFA-2 score within 7 days after randomization (or successful extubation, whichever comes first) and the baseline SOFA-2 score.

    Time frame: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  5. Time from study drug administration to first achievement of optimal sedation

    Time from randomization to first achievement of optimal sedation (optimal sedation defined based on the SQAT)

    Time frame: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  6. The proportion of rescue sedation

    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

    Time frame: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  7. The proportion of delirium

    Incidence and duration of delirium druing study period (CAM-ICU was assessed every 12 h after randomization during ICU)

    Time frame: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  8. Vasopressor-free days within 28-day after randomizaiton

    Time frame: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  9. The length of ICU stay

    Days randomization to ICU discharge

    Time frame: From randomization to ICU discharge ( up to 28 days after randomization)

  10. Mortality at 28 days and 90 days after randomization

    Time frame: From randomization to 90 days after randomization

  11. Intensive care unit experience at 28 days and 90 days after randomization

    ICU experience was measured using ICU experience questionnaire (ICEQ). This questionnaire comprises five dimensions and 21 items, with each item scored on a scale of 1 to 5, yielding a total score ranging from 21 to 105. Higher scores indicate a more favorable patient experience during ICU hospitalization.

    Time frame: From randomization to 90 days after randomization

  12. Health-related quality of life at 28 days and 90 days after randomization

    Health-related quality of life was measured using EQ-5D-5L questionnaire at the screening period, 28 days and 90 days after randomization. The EQ-5D-5L questionnaire comprises five dimensions, each scored from 1 to 5, with higher scores indicating poorer health status.

    Time frame: From the screening period (baseline) to 90 days after randomization

Other outcomes

  1. The proportion of sedation success

    The proportion of sedation success in each group during 0-24 h, 0-48 h, 0-72 h, 0-96 h, 0-120 h, or the treatment period (target sedation: -2 ≤ RASS ≤ +1, sedation success was defined as achieving the target sedation level for more than 70% of study drug administration duration without the need for rescue sedation)

    Time frame: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  2. Sedation attainment rate

    Sedation attainment rate was defined as the percentage of time with RASS -2 to +1 during study drug administration

    Time frame: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  3. Inflammatory cytokines and proteomics

    Plasma were collected at baseline, 24 h, 72 h, 7 days, and on the day of successful extubation

    Time frame: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

  4. PK plasma concentration

    Plasma were collected at baseline, 24 h, 72 h, 7 days after remimazolam infusion, and on the day of successful extubation

    Time frame: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study

07

Study locations

21 sites
  • Dongguan People's Hospital
    Dongguan, Guangdong 523059, China
  • First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
  • The Third Affiliated Hospital, Southern Medical University
    Guangzhou, Guangdong 510630, China
  • Longgang Central Hospital of Shenzhen
    Shenzhen, Guangdong, China
  • The First Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi 530021, China
  • The First Affiliated Hospital of Henan University of Science & Technology
    Luoyang, Henan, China
  • Zhengzhou Central Hospital
    Zhengzhou, Henan, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430060, China
  • Wuhan Third Hospital · Tongren Hospital of Wuhan University
    Wuhan, Hubei, China
  • Affiliated Hospital of Nantong University
    Nantong, Jiangsu, China
  • Wuxi People's Hospital
    Wuxi, Jiangsu 215023, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu, China
  • Qinghai University Affiliated Hospital
    Xining, Qinghai, China
  • Zibo Central Hospital
    Zibo, Shandong, China
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
  • The Affiliated Hospital of Southwest Medical University
    Luzhou, Sichuan, China
  • Sichuan Mianyang 404 Hospital
    Mianyang, Sichuan, China
  • Jinhua Municipal Central Hospital
    Jinhua, Zhejiang 321000, China
  • Lishui Central Hospital
    Lishui, Zhejiang 323000, China
  • The First Affiliated Hospital of Ningbo University
    Ningbo, Zhejiang, China
  • Peking University People's Hospital
    Beijing, 100044, China
08

References and documents

Publications

  • Li Y, Yuan Y, Zhou J, Ma L. Effect of remimazolam besylate on elderly patients with mechanical ventilation: a single-center randomized controlled study. BMC Anesthesiol. 2025 Feb 10;25(1):65. doi: 10.1186/s12871-025-02903-8. PubMed 39930338 ↗
  • Guan X, Liu N, Lin F, Yu J, Yang M, Zhou Q, Chen K, Yu X, Huang X, Zhu J, Lyu J, Gui C, Hu Z, Zheng S, He B, Wang M, Yu Z, Ma X, Lv A, Zhang J, Xu J, Ye J, Gong J, Tian X, Zhou J, Zhou F, Yu L, He W, Li X, Yin T, Zhao H, Ding Y, Chen M. Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: A Multicenter, Randomized, Single-blind, Noninferiority, Phase 3 Trial. Anesthesiology. 2026 Jul 1;145(1):72-83. doi: 10.1097/ALN.0000000000006047. Epub 2026 Mar 19. PubMed 41855428 ↗

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 19, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
Jul 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 2 updates
  1. Oct 21, 2026
    Minor edits only
    + 1 other change: secondary outcomes
  2. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07880548
Lead sponsor
Sun Yat-sen University
Responsible party
Wu Jianfeng (Professor, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Oct 19, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

Jianfeng Wu, professor
Contact
wujianf@mail.sysu.edu.cn
020-87755766-8454
Fei Pei, associate professor
Contact
peif3@mail.sysu.edu.cn
020-87755766-8454

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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