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The goal of this observational study is to explore the effect of remimazolam-based total intravenous anesthesia on postoperative neurocognitive function in patients who undergo cardiovascular surgery.
The main question this study tries to answer is: Does remimazolam influence the incidence of postoperative delirium in cardiovascular surgery? Participants already apply remimazolam-based total intravenous anesthesia as part of their regular medical treatment for general anesthesia to perform cardiac surgery will answer questionnaires about cognitive function after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | General anesthesia is remimazolam-based, combined with other intravenous agents. | ||
| Control | General anesthesia is propofol-based, combined with other intravenous agents. |
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| Measure | Description | Time Frame |
|---|---|---|
| the 5-day incidence of postoperative delirium | the incedence of delirium evaluated by CAM/CAM-ICU | within five days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | Time to extubation postoperatively | Perioperative |
| Length of stay (LOS) in intensive care unit (ICU) | Length of stay (LOS) in intensive care unit (ICU) postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Undergo elective cardiovascular surgery with cardiopulmonary bypass
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Shi, M.D. | Contact | +86 10 88322467 | shijia@fuwai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25535170 | Background | American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available. | |
| 29751986 | Background |
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Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. Additionally, the consent obtained from participants does not include provisions for data sharing, in accordance with ethical guidelines and institutional policies.
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| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Perioperative |
| Length of stay (LOS) in hospital | Length of stay (LOS) in hospital postoperatively | Perioperative |
| the 30-day composite incidence of major adverse events | Major adverse events refer to transient ischemic attack, stroke, renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality. | within 30 days postoperatively |
|
| Sanson G, Khlopenyuk Y, Milocco S, Sartori M, Dreas L, Fabiani A. Delirium after cardiac surgery. Incidence, phenotypes, predisposing and precipitating risk factors, and effects. Heart Lung. 2018 Jul-Aug;47(4):408-417. doi: 10.1016/j.hrtlng.2018.04.005. Epub 2018 May 8. |
| 38987101 | Background | Varsha AV, Unnikrishnan KP, Saravana Babu MS, Raman SP, Koshy T. Comparison of Propofol-Based Total Intravenous Anesthesia versus Volatile Anesthesia with Sevoflurane for Postoperative Delirium in Adult Coronary Artery Bypass Grafting Surgery: A Prospective Randomized Single-Blinded Study. J Cardiothorac Vasc Anesth. 2024 Sep;38(9):1932-1940. doi: 10.1053/j.jvca.2024.05.027. Epub 2024 May 23. |
| 38284956 | Background | Grant MC, Crisafi C, Alvarez A, Arora RC, Brindle ME, Chatterjee S, Ender J, Fletcher N, Gregory AJ, Gunaydin S, Jahangiri M, Ljungqvist O, Lobdell KW, Morton V, Reddy VS, Salenger R, Sander M, Zarbock A, Engelman DT. Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28. |
| 39975717 | Background | Yu YR, Wang YL, Zhu XW, Li L, Wang DJ, Wang YP, Ye JX. Effect of dexmedetomidine on postoperative delirium in patients undergoing type A aortic dissection surgery: a prospective cohort study. J Thorac Dis. 2025 Jan 24;17(1):161-173. doi: 10.21037/jtd-24-1219. Epub 2025 Jan 22. |
| 40912002 | Background | Shen J, Wang L, Liu Y, Li T, Zhu L, Li Z, Shi J, Lv H. Remimazolam besylate versus propofol as sedative agents in cardiac surgery: A randomized noninferiority clinical trial. Surgery. 2025 Nov;187:109661. doi: 10.1016/j.surg.2025.109661. Epub 2025 Sep 4. |
| 23992774 | Background | Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28. |
| 27119013 | Background | O'Neal JB, Shaw AD. Predicting, preventing, and identifying delirium after cardiac surgery. Perioper Med (Lond). 2016 Apr 26;5:7. doi: 10.1186/s13741-016-0032-5. eCollection 2016. |