REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2)

August 19, 2025 updated by: Nanfang Hospital, Southern Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7188

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Chongqing Western Hospital
        • Contact:
      • Chongqing, China
        • Recruiting
        • Liangjiang Hospital of Chongqing Medical University
        • Contact:
    • Anhui
      • Hefei, Anhui, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Huainan, Anhui, China
        • Recruiting
        • Huainanchaoyang Hospital
        • Contact:
      • Suzhou, Anhui, China
        • Recruiting
        • Suzhou First People's Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100016
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Recruiting
        • Xinqiao Hospital of Chongqing
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • Southern Medical University Zhujiang Hospital
        • Contact:
      • Zhongshan, Guangdong, China
        • Recruiting
        • Zhongshan City People's Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Kaili, Guizhou, China
        • Recruiting
        • Qiandongnanzhou People's Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Kaifeng, Henan, China
        • Recruiting
        • Kaifeng Central Hospital
        • Contact:
      • Pingdingshan, Henan, China
        • Recruiting
        • The 989 Hospital of the People's Liberation Army Joint Support Force
        • Contact:
      • Shangqiu, Henan, China
        • Recruiting
        • Shangqiu Third People's Hospital
        • Contact:
      • Xuchang, Henan, China
        • Recruiting
        • Changge People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Province Hospital of TCM
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Wuhan University People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410002
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
        • Contact:
      • Hengyang, Hunan, China
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College
        • Contact:
      • Baotou, Inner Mongolia, China
        • Recruiting
        • The Second Affiliated Hospital of Baotou Medical College
        • Contact:
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • The Second Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • General Hospital of Northern Theater Command
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
        • Contact:
      • Zibo, Shandong, China
        • Recruiting
        • The 960th Hospital of the PLA Joint Logistic Support Force
        • Contact:
    • Shanxi
      • Baoji, Shanxi, China
        • Recruiting
        • Bao Ji City People's Hospital（BaoJi Emergency Medical Center）
        • Contact:
      • Fenyang, Shanxi, China
        • Recruiting
        • Fenyang Hospital of Shanxi Province
        • Contact:
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Mengchang Yang, MD
          • Phone Number: 86-18140049936
          • Email: ymc681@126.com
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Recruiting
        • The first affiliated hospital of Xinjiang medical university
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
      • Kunming, Yunnan, China, 650028
        • Recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. history of coronary artery disease;
    2. history of stroke;
    3. history of congestive heart failure;
    4. preoperative NT-proBNP >200 pg/mL or BNP>92 pg/mL;
    5. age ≥70 years;
    6. diabetes requiring medical treatment;
    7. ASA status 3 or 4;
    8. history of chronic kidney disease (preoperative sCr >133 μmol/L or 1.5 mg/dL);
    9. history of peripheral arterial disease;
    10. preoperative serum albumin <30 g/L;
    11. preoperative hemoglobin <100 g/L.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam TIVA
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.
Drug: Remimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Active Comparator: Propofol TIVA
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.
Drug: Propofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days alive and out of hospital at day 30
Time Frame: 30 days after randomization
Number of days alive and out of hospital
30 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause 30-day mortality
Time Frame: 30 days after randomization
Number of patients who die of any cause
30 days after randomization
Length of hospital stay
Time Frame: 30 days after randomization
Number of days in hospital
30 days after randomization
Unplanned re-hospitalization
Time Frame: 30 days after randomization
Number of patients who experience unplanned hospital re-admissions
30 days after randomization
Postoperative complications
Time Frame: 30 days after randomization
Number of patients who experience postoperative complications
30 days after randomization
Quality of Recovery-15 score on the first day after surgery
Time Frame: Postoperative day 1
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.
Postoperative day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer recurrence
Time Frame: 3 years after randomization
Number of patients who experience cancer recurrence after radical resection of cancer
3 years after randomization
All-cause 3-year mortality
Time Frame: 3 years after randomization
Number of patients who die of any cause
3 years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

One year after the main trial result is published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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