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NCT Number: NCT05728775

REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

Remimazolam

Drug

Remimazolam is administered intravenously for induction and maintenance of general anesthesia.

Propofol

Drug

Propofol is administered intravenously for induction and maintenance of general anesthesia.

Primary outcomes

  1. Days alive and out of hospital at day 30

    Time frame: 30 days after randomization

    Number of days alive and out of hospital

Secondary outcomes

  1. All-cause 30-day mortality

    Time frame: 30 days after randomization

    Number of patients who die of any cause

  2. Length of hospital stay

    Time frame: 30 days after randomization

    Number of days in hospital

  3. Unplanned re-hospitalization

    Time frame: 30 days after randomization

    Number of patients who experience unplanned hospital re-admissions

  4. Postoperative complications

    Time frame: 30 days after randomization

    Number of patients who experience postoperative complications

  5. 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.

Other outcomes

  1. Cancer recurrence

    Time frame: 3 years after randomization

    Number of patients who experience cancer recurrence after radical resection of cancer

  2. All-cause 3-year mortality

    Time frame: 3 years after randomization

    Number of patients who die of any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Bingcheng Zhao, MD

CONTACT

[email protected]

86-13763313653

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial

Acronym: REPOSE-2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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