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

Anesthesia Clinical Trial

— REPOSE-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728775
• Other study ID #: NFEC-2022-286
• Status: Recruiting
• Phase: Phase 4
• Start date: April 3, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Bingcheng Zhao, MD
• Phone: 86-13763313653
• Email: zhaobch[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7188
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Remimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
• Propofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Xinqiao Hospital of Chongqing	Chongqing	Chongqing
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	Southern Medical University Zhujiang Hospital	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Wuhan University People's Hospital	Wuhan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cancer recurrence	Number of patients who experience cancer recurrence after radical resection of cancer	3 years after randomization
Other	All-cause 3-year mortality	Number of patients who die of any cause	3 years after randomization
Primary	Days alive and out of hospital at day 30	Number of days alive and out of hospital	30 days after randomization
Secondary	All-cause 30-day mortality	Number of patients who die of any cause	30 days after randomization
Secondary	Length of hospital stay	Number of days in hospital	30 days after randomization
Secondary	Unplanned re-hospitalization	Number of patients who experience unplanned hospital re-admissions	30 days after randomization
Secondary	Postoperative complications	Number of patients who experience postoperative complications	30 days after randomization
Secondary	Quality of Recovery-15 score on the first day after surgery	Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.	Postoperative day 1