Clinical trial NCT05728775: REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
Official title: REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Surgery-Complications
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 7188
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Days alive and out of hospital at day 30
timeFrame: 30 days after randomization
Secondary outcomes:
measure: All-cause 30-day mortality
timeFrame: 30 days after randomization
measure: Length of hospital stay
timeFrame: 30 days after randomization
measure: Unplanned re-hospitalization
timeFrame: 30 days after randomization
measure: Postoperative complications
timeFrame: 30 days after randomization
measure: Quality of Recovery-15 score on the first day after surgery
timeFrame: Postoperative day 1
Other outcomes:
measure: Cancer recurrence
timeFrame: 3 years after randomization
measure: All-cause 3-year mortality
timeFrame: 3 years after randomization
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
state: Chongqing
city: Guangzhou
country: China
facility: Southern Medical University Zhujiang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References: