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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
7,188
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Propofol is administered intravenously for induction and maintenance of general anesthesia.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGHuainanchaoyang Hospital
Huainan, Anhui, China
RECRUITINGSuzhou First People's Hospital
Suzhou, Anhui, China
RECRUITINGBeijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Days alive and out of hospital at day 30
Number of days alive and out of hospital
Time frame: 30 days after randomization
All-cause 30-day mortality
Number of patients who die of any cause
Time frame: 30 days after randomization
Length of hospital stay
Number of days in hospital
Time frame: 30 days after randomization
Unplanned re-hospitalization
Number of patients who experience unplanned hospital re-admissions
Time frame: 30 days after randomization
Postoperative complications
Number of patients who experience postoperative complications
Time frame: 30 days after randomization
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.
Time frame: Postoperative day 1
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Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, China
RECRUITINGThe First People's Hospital of Foshan
Foshan, Guangdong, China
RECRUITINGSouthern Medical University Zhujiang Hospital
Guangzhou, Guangdong, China
RECRUITINGSouthern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGZhongshan City People's Hospital
Zhongshan, Guangdong, China
RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
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