AnesthesiaPhase 4REPOSE-2NCT05728775
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
A Phase 4 study testing Remimazolam and Propofol in people with Anesthesia and Surgery-Complications, run by Nanfang Hospital, Southern Medical University at 44 sites in China.
Trial summary
The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Anesthesia, Surgery-Complications
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,188 participants
- Where
- 44 sitesChina
- Study dates
- 3 Apr 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥45 years;
- Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);
- Fulfilling ≥1 of the following criteria:
- history of coronary artery disease;
- history of stroke;
- history of congestive heart failure;
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- preoperative NT-proBNP >200 pg/mL or BNP>92 pg/mL;
- age ≥70 years;
- diabetes requiring medical treatment;
- ASA status 3 or 4;
- history of chronic kidney disease (preoperative sCr >133 μmol/L or 1.5 mg/dL);
- history of peripheral arterial disease;
- preoperative serum albumin <30 g/L;
- preoperative hemoglobin <100 g/L.
Who cannot join
- Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations;
- Low risk or minor surgery
- End-stage renal disease requiring renal-replacement therapy;
- Hepatic dysfunction (Child B or C);
- Previous liver or kidney transplantation;
- Previous allergy to general anesthetics;
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- Unable to receive bispectral index monitoring;
- ASA score ≥5;
- Exposure to general anesthesia in prior 30 days or anticipated re-exposure to general anesthesia within 30 days after surgery;
- Need for prolonged airway protection or mechanical ventilatory support after surgery;
- Current participation in another interventional study;
- Previous participation in this study;
- Pregnant or breastfeeding women.
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
China44 sites, 44 recruiting
- Recruiting
Bao Ji City People's Hospital（BaoJi Emergency Medical Center）
Baoji, Shanxi
Zhifu Chen, 86-18191796266, 447228810@qq.com
- Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia
Manhai Gao, 86-18047211255, 1577703601@qq.com
- Recruiting
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia
Rui Gao, 86-13947285566, 315446772@qq.com
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100016
Anshi Wu, MD, 86-13511010883, wuanshi88@163.com
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410002
Gaoyin Kong, MD, 86-13908476981, konggaoyin@sina.com
- Recruiting
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan
Gaoyin Kong, 86-13908476981, konggaoyin@sina.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Mengchang Yang, MD, 86-18140049936, ymc681@126.com
- Recruiting
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, 400037
Hong Li, MD, 86-13608380123, 442479485@qq.com
- Recruiting
Chongqing Western Hospital
Chongqing
Hejiang Zhong, 86-13996283655, zhong_zhj@163.com
- Recruiting
Liangjiang Hospital of Chongqing Medical University
Chongqing
Gu Wu, 86-13983090602, cqumswugu@qq.com
- Recruiting
Fenyang Hospital of Shanxi Province
Fenyang, Shanxi
Yong Gao, 86-13133080863, gaoyong9596@126.com
- Recruiting
The First People's Hospital of Foshan
Foshan, Guangdong
Jian He, 86-18038865078, hejian2011@126.com
- Recruiting
Southern Medical University Zhujiang Hospital
Guangzhou, Guangdong, 510260
Hongfei Zhang, MD, 86-15625059521, zhanghongfei@smu.edu.cn
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Bingcheng Zhao, 86-13763313653, zhaobch@mail2.sysu.edu.cn
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
Xiaohua Zou, MD, 86-13809416036, 562931613@qq.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Xuesheng Liu, MD, 86-18655193385, liuxuesheng@ahmu.edu.cn
- Recruiting
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan
Chao Li, 86-13575158507, 8993328@qq.com
- Recruiting
The Second Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Caixia Wang, 86-15049100649, caixia6915@sina.com
- Recruiting
Huainanchaoyang Hospital
Huainan, Anhui
Xiaxi Liu, 86-17755436061, liuxiaxi8050@sina.com
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Jianbo Wu, 86-13805319310, jianbowu@126.com
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan
Weizhong He, 86-18603780612, hwz9861@163.com
- Recruiting
Qiandongnanzhou People's Hospital
Kaili, Guizhou
Zhihui Zhang, 86-15808559555, 3304272161@qq.com
- Recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650028
Yun Bo, MD, 86-13987141066, 78377129@qq.com
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Jianlin Shao, MD, 86-13888586162, cmushaojl@aliyun.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Guohai Xu, MD, 86-13970008916, xuguohai@sina.com
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Cunming Liu, MD, 86-13951890866, 1335587409@qq.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Yiwei Zhang, 86-17757461135, fyyzhangyiwei@nbu.edu.cn
- Recruiting
The 989 Hospital of the People's Liberation Army Joint Support Force
Pingdingshan, Henan
Ling Wang, 86-13703790096, wanglilly2022@126.com
- Recruiting
Shangqiu Third People's Hospital
Shangqiu, Henan
Sen Zhu, 86-15896973093, 1012290208@qq.com
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Yugang Diao, MD, 86-15309881160, diao72@163.com
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Chao Li, MD, 86-18531116660, jysylichao@163.com
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Li Wang, 86-13933170139, lw79812@163.com
- Recruiting
Suzhou First People's Hospital
Suzhou, Anhui
Xiangfei Zhang, 86-18955708907, 315187572@qq.com
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Jieping Lv, MD, 86-13593131366, 691597018@qq.com
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Weiwei Zhang, 86-13466833989, 2195531857@qq.com
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Jianrong Ye, 86-18999938777, 616227972@qq.com
- Recruiting
Wuhan University People's Hospital
Wuhan, Hubei, 430060
Shaoqing Lei, MD, 86-18707195909, leishaoqing@163.com
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei
Jingli Chen, 86-13971200472, chenjinli2001@sina.com
- Recruiting
Changge people's hospital
Xuchang, Henan
Peng Qin, 86-19903997782, 413471784@qq.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Jiaqiang Zhang, MD, 86-18538298056, zhangjiq@zzu.edu.cn
- Recruiting
Henan Province Hospital of TCM
Zhengzhou, Henan
Yunliang Guo, 86-13523567687, 314637789@qq.com
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Feng Yuan, 86-13523099337, 13523099337@163.com
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong
Xiaozu Liao, 86-13450921219, liaoxiaozu@163.com
- Recruiting
The 960th Hospital of the PLA Joint Logistic Support Force
Zibo, Shandong
Chengjie Gao, 86-15628813107, gaochj@hotmail.com
About this study
Official title: REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.
- Conditions
- Anesthesia, Surgery-Complications
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
PropofolDrug
Propofol is administered intravenously for induction and maintenance of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam TIVA | Experimental | Remimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60. Receives: Drug: Remimazolam |
| Propofol TIVA | Active comparator | Propofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital at day 30
Number of days alive and out of hospital
Measured: 30 days after randomization
Secondary outcomes (5)
All-cause 30-day mortality
Number of patients who die of any cause
Measured: 30 days after randomization
Length of hospital stay
Number of days in hospital
Measured: 30 days after randomization
Unplanned re-hospitalization
Number of patients who experience unplanned hospital re-admissions
Measured: 30 days after randomization
Postoperative complications
Number of patients who experience postoperative complications
Measured: 30 days after randomization
Quality of Recovery-15 score on the first day after surgery
Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start3 Apr 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728775
- Sponsor's protocol ID
- NFEC-2022-286
- Acronym
- REPOSE-2
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05728775
- Acronym / sponsor ID
- REPOSE-2 / NFEC-2022-286
- Conditions
- Anesthesia, Surgery-Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,188 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam TIVA | Experimental | Drug: RemimazolamRemimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60. |
| Propofol TIVA | Active comparator | Drug: PropofolPropofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥45 years;
- Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);
- Fulfilling ≥1 of the following criteria:
Key exclusion criteria (13 listed)
- Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations;
- Low risk or minor surgery
- End-stage renal disease requiring renal-replacement therapy;
- Hepatic dysfunction (Child B or C);
- Previous liver or kidney transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamRemimazolam is administered intravenously for induction and maintenance of general anesthesia. | Drug | Remimazolam TIVA |
| PropofolPropofol is administered intravenously for induction and maintenance of general anesthesia. | Drug | Propofol TIVA |
Primary outcome
Days alive and out of hospital at day 30
Time frame: 30 days after randomization
Number of days alive and out of hospital
5 secondary outcomes
All-cause 30-day mortality
Time frame: 30 days after randomization
Length of hospital stay
Time frame: 30 days after randomization
Unplanned re-hospitalization
Time frame: 30 days after randomization
Postoperative complications
Time frame: 30 days after randomization
Quality of Recovery-15 score on the first day after surgery
Time frame: Postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Propofol in people with Anesthesia and Surgery-Complications, run by Nanfang Hospital, Southern Medical University at 44 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingcheng Zhao, MD (86-13763313653, zhaobch@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and out of hospital at day 30 (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.