Comparing remimazolam and propofol for anesthesia in major surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to evaluate the effectiveness of total intravenous anesthesia using remimazolam compared to propofol in patients at moderate-to-high risk undergoing major elective noncardiac surgeries. The primary focus is to determine if remimazolam can lead to more days alive and out of the hospital by postoperative day 30. Eligible participants include those aged 45 and older with specific health conditions that increase surgical risk. The study will assess outcomes related to anesthesia management and postoperative recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Huainanchaoyang Hospital
  Huainan, Anhui, China Recruiting
• Suzhou First People's Hospital
  Suzhou, Anhui, China Recruiting
• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Xinqiao Hospital of Chongqing
  Chongqing, Chongqing Municipality, China Recruiting
• The First People's Hospital of Foshan
  Foshan, Guangdong, China Recruiting

Study contacts

• Study coordinator: Bingcheng Zhao, MD
• Email: zhaobch@mail2.sysu.edu.cn
• Phone: 86-13763313653

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.