REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Anesthesia, Surgery-Complications. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- Drug Remimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia. - Drug Propofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.
Primary outcome measures
- Days alive and out of hospital at day 30 [Time frame: 30 days after randomization]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
China · 44 centers
- The First Affiliated Hospital of Anhui Medical University — Hefei
- Huainanchaoyang Hospital — Huainan
- Suzhou First People's Hospital — Suzhou
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
- Xinqiao Hospital of Chongqing — Chongqing
- The First People's Hospital of Foshan — Foshan
- Southern Medical University Zhujiang Hospital — Guangzhou
- Southern Medical University Nanfang Hospital — Guangzhou
- … and 36 more centers
Identifiers
NCT: NCT05728775 · NFEC-2022-286