REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
REPOSE-2
1 other identifier
interventional
7,188
1 country
44
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2023
Longer than P75 for phase_4
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 26, 2025
August 1, 2025
4.7 years
February 6, 2023
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Days alive and out of hospital at day 30
Number of days alive and out of hospital
30 days after randomization
Secondary Outcomes (5)
All-cause 30-day mortality
30 days after randomization
Length of hospital stay
30 days after randomization
Unplanned re-hospitalization
30 days after randomization
Postoperative complications
30 days after randomization
Quality of Recovery-15 score on the first day after surgery
Postoperative day 1
Other Outcomes (2)
Cancer recurrence
3 years after randomization
All-cause 3-year mortality
3 years after randomization
Study Arms (2)
Remimazolam TIVA
EXPERIMENTALRemimazolam 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 COMPARATORPropofol 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.
Interventions
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Propofol is administered intravenously for induction and maintenance of general anesthesia.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Huainanchaoyang Hospital
Huainan, Anhui, China
Suzhou First People's Hospital
Suzhou, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100016, China
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, 400037, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Southern Medical University Zhujiang Hospital
Guangzhou, Guangdong, 510260, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
Qiandongnanzhou People's Hospital
Kaili, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Kaifeng Central Hospital
Kaifeng, Henan, China
The 989 Hospital of the People's Liberation Army Joint Support Force
Pingdingshan, Henan, China
Shangqiu Third People's Hospital
Shangqiu, Henan, China
Changge people's hospital
Xuchang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Henan Province Hospital of TCM
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan University People's Hospital
Wuhan, Hubei, 430060, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410002, China
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
The Second Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016, China
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
The 960th Hospital of the PLA Joint Logistic Support Force
Zibo, Shandong, China
Bao Ji City People's Hospital（BaoJi Emergency Medical Center）
Baoji, Shanxi, China
Fenyang Hospital of Shanxi Province
Fenyang, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650028, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Chongqing Western Hospital
Chongqing, China
Liangjiang Hospital of Chongqing Medical University
Chongqing, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2023
First Posted
February 15, 2023
Study Start
April 3, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- One year after the main trial result is published.