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

RecruitingPhase 4Ages 45 Years - anyAllNanfang Hospital, Southern Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Remimazolam
  • Propofol
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Where

44 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huainanchaoyang Hospital
Huainan, China
Suzhou First People's Hospital
Suzhou, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
Xinqiao Hospital of Chongqing
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
Southern Medical University Zhujiang Hospital
Guangzhou, China
Southern Medical University Nanfang Hospital
Guangzhou, China

…and 36 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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