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

Recruiting now · Phase 4

Conditions studied: Anesthesia, Surgery-Complications

In brief

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.

Key facts

Study ID

NCT05728775

Run by

Nanfang Hospital, Southern Medical University

People needed

7188

Starts

2023-04-03

Expected to finish

2027-12-31

Last updated by the study team

2025-08-26

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Huainanchaoyang Hospital — Huainan, Anhui, China (enrolling)
• Suzhou First People's Hospital — Suzhou, Anhui, China (enrolling)
• Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Xinqiao Hospital of Chongqing — Chongqing, Chongqing Municipality, China (enrolling)
• The First People's Hospital of Foshan — Foshan, Guangdong, China (enrolling)
• Southern Medical University Zhujiang Hospital — Guangzhou, Guangdong, China (enrolling)
• Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China (enrolling)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (enrolling)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (enrolling)
• Qiandongnanzhou People's Hospital — Kaili, Guizhou, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Kaifeng Central Hospital — Kaifeng, Henan, China (enrolling)
• The 989 Hospital of the People's Liberation Army Joint Support Force — Pingdingshan, Henan, China (enrolling)
• Shangqiu Third People's Hospital — Shangqiu, Henan, China (enrolling)
• Changge people's hospital — Xuchang, Henan, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Henan Province Hospital of TCM — Zhengzhou, Henan, China (enrolling)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Wuhan University People's Hospital — Wuhan, Hubei, China (enrolling)
• The Central Hospital of Wuhan — Wuhan, Hubei, China (enrolling)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (enrolling)
• Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital Of University Of South China — Hengyang, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.