Comparing remimazolam and propofol for anesthesia in major surgeries

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

This study is testing whether a new anesthesia drug called remimazolam can help older patients undergoing major surgeries recover better and spend more days out of the hospital compared to the standard drug, propofol.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7188 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 44 sites (Hefei, Anhui and 43 other locations)
• Trial ID: NCT05728775 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45 and older who are undergoing elective major surgery and have at least one risk factor for complications.

Not a fit: Patients undergoing low-risk or minor surgeries, or those with severe hepatic or renal dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve postoperative recovery and reduce complications for patients undergoing major surgeries.

How similar studies have performed: Previous studies have shown promising results with remimazolam in anesthesia, suggesting potential benefits over traditional agents like propofol.

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:

  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 this trial is running

Hefei, Anhui and 43 other locations

• 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)
• Southern Medical University Zhujiang Hospital — Guangzhou, Guangdong, China (Recruiting)
• Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (Recruiting)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• Qiandongnanzhou People's Hospital — Kaili, Guizhou, China (Recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Kaifeng Central Hospital — Kaifeng, Henan, China (Recruiting)
• The 989 Hospital of the People's Liberation Army Joint Support Force — Pingdingshan, Henan, China (Recruiting)
• Shangqiu Third People's Hospital — Shangqiu, Henan, China (Recruiting)
• Changge people's hospital — Xuchang, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Province Hospital of TCM — Zhengzhou, Henan, China (Recruiting)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Wuhan University People's Hospital — Wuhan, Hubei, China (Recruiting)
• The Central Hospital of Wuhan — Wuhan, Hubei, China (Recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Recruiting)
• Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital Of University Of South China — Hengyang, Hunan, China (Recruiting)
• The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China (Recruiting)
• The Second Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China (Recruiting)
• The Second Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)
• The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)
• The 960th Hospital of the PLA Joint Logistic Support Force — Zibo, Shandong, China (Recruiting)
• Bao Ji City People's Hospital（BaoJi Emergency Medical Center） — Baoji, Shanxi, China (Recruiting)
• Fenyang Hospital of Shanxi Province — Fenyang, Shanxi, China (Recruiting)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Shanxi Provincial People's Hospital — Taiyuan, Shanxi, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
• The First People's Hospital of Yunnan Province — Kunming, Yunnan, China (Recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• Chongqing Western Hospital — Chongqing, China (Recruiting)
• Liangjiang Hospital of Chongqing Medical University — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Bingcheng Zhao, MD

Conditions Anesthesia; Surgery-Complications