Long-term Sedation for Mechanical VentilationPhase 3RePro-ICUNCT07880548

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

A Phase 3 study testing Remimazolam group and Propofol group in people with Long-term Sedation for Mechanical Ventilation and Critically Ill Intensive Care Unit Patients, run by Sun Yat-sen University at 21 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
What is being tested?: Remimazolam group and Propofol group
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 274 participants
Where: 21 sitesChina
Study dates: 20 Oct 2026to 31 Aug 2028
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years;
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;
At the time of randomization, more than 24 h of further mechanical ventilation is anticipated;
The attending clinician determines that sedation therapy is required;
the subject and/or their legal guardian signs the informed consent form (ICF);
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.

Who cannot join

History of hypersensitivity to benzodiazepines, propofol, remifentanil, or to any of their components or excipients;
Severe neurological disease (e.g., myasthenia gravis, severe depression, schizophrenia, severe traumatic brain injury, massive cerebral infarction, status epilepticus, intracranial tumor, post-neurosurgical status);
Post-cardiac arrest (with clinician-assessed hypoxic-ischemic brain injury);
Subjects who require or are expected to require neuromuscular blocking agents after ICU admission;
Pregnant or breastfeeding women;
Life expectancy less than 24 hours;

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Receipt of palliative care;
Hospice patients;
Severe hepatic impairment (Child-Pugh class C);
Participation in another clinical trial of an investigational drug with prior receipt of that drug;
Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jianfeng Wu, professor contact

020-87755766-8454

wujianf@mail.sysu.edu.cn

Fei Pei, associate professor contact

020-87755766-8454

peif3@mail.sysu.edu.cn

City, postcode or hospital

21 sites in 1 country

China21 sites

Peking University People's Hospital
Beijing, 100044
Fengxue Zhu, +86-13911005275, fxzhu72@163.com
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Chun Pan, +86-13814009925, panchun1982@gmail.com
Dongguan People's Hospital
Dongguan, Guangdong, 523059
Lihan Shen, +86-15812892728, shenlihan@hotmail.com
First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jianfeng Wu, professor, 020-87755766-8454, wujianf@mail.sysu.edu.cn
Fei Pei, associate professor, 020-87755766-8454, peif3@mail.sysu.edu.cn
The Third Affiliated Hospital, Southern Medical University
Guangzhou, Guangdong, 510630
Fen Li, +86-13760871441, lf1909@smu.edu.cn
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Kun Chen, +86-15005790115, 13957090707@sina.com
Lishui Central Hospital
Lishui, Zhejiang, 323000
Xin Tian, +86-13567615537, yqjytx@163.com
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Yongmei Zhang, +86-13683861918, zzyymm666@sina.com
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Xianying Lei, +86-13320741667, leixianying310@swmu.edu.cn
Sichuan Mianyang 404 Hospital
Mianyang, Sichuan
Bo Hu, +86-13458307105, hubo03074@sina.com
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Ting Zhou, +86-18477190940, 921132@sr.gxmu.edu.cn
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Yang Lu, +86-13338065665, marineluyang@ntu.edu.cn
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Jianwei Yue, +86-13600629095, 985155712@qq.com
Longgang Central Hospital of Shenzhen
Shenzhen, Guangdong
Ronglin Chen, +86-15734840653, 1450164138@qq.com
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Liying Zhan, +86-15327408448, 2582062108@qq.com
Wuhan Third Hospital · Tongren Hospital of Wuhan University
Wuhan, Hubei
Fang Dong, +86-15377628292, weiyuyan1981@163.com
Wuxi People's Hospital
Wuxi, Jiangsu, 215023
Fengming Liang, +86-13861714007, liangnanyi@sina.com
Qinghai University Affiliated Hospital
Xining, Qinghai
Chunjian Ma, +86-15297139876, 1135741024@qq.com
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Yali Chao, +86-13705216327, chaoyali@126.com
Zhengzhou Central Hospital
Zhengzhou, Henan
Lanjuan Xu, +86-13783508216, lichengjian125@163.com
Zibo Central Hospital
Zibo, Shandong
Meiling Zhao, +86-18678186875, 1939171815@qq.com

Other trials in China

About this study

Official title: Remimazolam Tosylate for Long-Term Sedation in Mechanically Ventilated ICU Patients: A Multicenter, Randomized, Propofol-Controlled, Non-Inferiority Study

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).

Conditions: Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Being tested: Remimazolam group, Propofol group
Keywords: Remimazolam tosilate, Propofol, Mechanical ventilation, ICU sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remimazolam groupDrug
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.
Propofol groupDrug
Also called Propofol medium/long-chain fat emulsion injection
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.

Study groups in NCT07880548
Study group	Role	What they receive
Remimazolam group	Experimental	Not described Receives: Drug: Remimazolam group
Propofol group	Active comparator	Not described Receives: Drug: Propofol group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From randomization to 28 days after randomization

Secondary outcomes (12)

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.
Measured: 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
Change from baseline to daily vasoactive-inotropic score within the 7 days (or successful extubation) after randomization
Measured: 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 follow-up in total cholesterol and triglycerides
total cholesterol and triglycerides are measured at the screening period (baseline) and every 7 days after randomization
Measured: 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 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.
Measured: From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study
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)
Measured: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study
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
Measured: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study
The proportion of delirium
Incidence and duration of delirium druing study period (CAM-ICU was assessed every 12 h after randomization during ICU)
Measured: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study
Vasopressor-free days within 28-day after randomizaiton
Measured: From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study
The length of ICU stay
Days randomization to ICU discharge
Measured: From randomization to ICU discharge ( up to 28 days after randomization)
Mortality at 28 days and 90 days after randomization
Measured: From randomization to 90 days after randomization
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.
Measured: From randomization to 90 days after randomization
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.
Measured: From the screening period (baseline) to 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202631 Aug 2028

First posted19 Oct 2026
Study start20 Oct 2026 (estimated)
Primary completion31 Jul 2028 (estimated)
Study completion31 Aug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Long-term Sedation for Mechanical VentilationStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, pragmatic, open-label, 1:1 randomized, active-controlled, non-inferiority trial
Masking: None (open label)
Enrolment: 274 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07880548
Sponsor's protocol ID: MA-ANE-IIT-RBN-007
Acronym: RePro-ICU
Status last verified: Oct 2026
First submitted: 12 Oct 2026
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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