REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
NCT ID: NCT05728775
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
7188 participants
INTERVENTIONAL
2023-04-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Remimazolam TIVA
Remimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
Remimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Propofol TIVA
Propofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
Propofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.
Interventions
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Remimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Propofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Huainanchaoyang Hospital
Huainan, Anhui, China
Suzhou First People's Hospital
Suzhou, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Southern Medical University Zhujiang Hospital
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Qiandongnanzhou People's Hospital
Kaili, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Kaifeng Central Hospital
Kaifeng, Henan, China
The 989 Hospital of the People's Liberation Army Joint Support Force
Pingdingshan, Henan, China
Shangqiu Third People's Hospital
Shangqiu, Henan, China
Changge people's hospital
Xuchang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Henan Province Hospital of TCM
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan University People's Hospital
Wuhan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
The Second Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
The 960th Hospital of the PLA Joint Logistic Support Force
Zibo, Shandong, China
Bao Ji City People's Hospital（BaoJi Emergency Medical Center）
Baoji, Shanxi, China
Fenyang Hospital of Shanxi Province
Fenyang, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Chongqing Western Hospital
Chongqing, , China
Liangjiang Hospital of Chongqing Medical University
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2022-286
Identifier Type: -
Identifier Source: org_study_id
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