Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China
Introduction Postoperative delirium (POD) is a common and serious complication in older adult patients undergoing cardiovascular surgery. Esketamine is known for its anti-inflammatory and neuroprotective properties. While it has shown preventive effects on POD in those not undergoing cardiovascular...
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BMJ Publishing Group
2025-06-01
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| author | Wei Zhang Liang Zhao Ju-Min Yan Qing-Ren Liu Jian-Jun Yang Hong-Qi Lin Zhao-Yu Wen Hao-Ran Zhang Yi-Xin Mei Rui-Di Wang |
| author_facet | Wei Zhang Liang Zhao Ju-Min Yan Qing-Ren Liu Jian-Jun Yang Hong-Qi Lin Zhao-Yu Wen Hao-Ran Zhang Yi-Xin Mei Rui-Di Wang |
| author_sort | Wei Zhang |
| collection | DOAJ |
| description | Introduction Postoperative delirium (POD) is a common and serious complication in older adult patients undergoing cardiovascular surgery. Esketamine is known for its anti-inflammatory and neuroprotective properties. While it has shown preventive effects on POD in those not undergoing cardiovascular surgery, its efficacy in older adult patients undergoing cardiovascular surgery remains uncertain. Therefore, we herein aimed to evaluate the preventive effect of intraoperative subanaesthetic esketamine on POD in this specific population.Methods and analysis This single-centre, randomised, double-blind, placebo-controlled trial will enrol 778 patients aged 60–80 years undergoing open-heart cardiovascular surgery in China, from September 2023 to December 2025. The participants will be randomly assigned in a 1:1 ratio to the following groups: the esketamine group and the control group. In the esketamine group, esketamine (2 mg/mL) will be administered intravenously at a dosage of 0.3 mg/kg over 10 min following tracheal intubation, followed by a continuous infusion at 0.15 mg/kg/h until the end of the surgery. Patients in the control group will receive a placebo following the same dosage and regimen. The incidence of POD will be the primary outcome and will be assessed twice daily from the first to the seventh postoperative day. The postoperative sleep quality, duration of postoperative mechanical ventilation, and length of hospital and intensive care unit stay will be the secondary outcomes.Ethics and dissemination Ethical approval was obtained from the Institutional Review Board of Fuwai Central China Cardiovascular Hospital (No. 2023068). Public disclosure is guaranteed post-trial, and the results will be published in a peer-reviewed scientific journal.Trial registration number ChiCTR2300074395. |
| format | Article |
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| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-0b4a19ee309942e1a7f352badf300a082025-08-20T03:21:24ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-089719Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in ChinaWei Zhang0Liang Zhao1Ju-Min Yan2Qing-Ren Liu3Jian-Jun Yang4Hong-Qi Lin5Zhao-Yu Wen6Hao-Ran Zhang7Yi-Xin Mei8Rui-Di Wang9Department of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaDepartment of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaDepartment of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, ChinaDepartment of Anesthesiology, Wuxi Xishan People’s Hospital, Wuxi, Jiangsu, ChinaDepartment of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, ChinaDepartment of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaDepartment of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaDepartment of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaDepartment of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaDepartment of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, ChinaIntroduction Postoperative delirium (POD) is a common and serious complication in older adult patients undergoing cardiovascular surgery. Esketamine is known for its anti-inflammatory and neuroprotective properties. While it has shown preventive effects on POD in those not undergoing cardiovascular surgery, its efficacy in older adult patients undergoing cardiovascular surgery remains uncertain. Therefore, we herein aimed to evaluate the preventive effect of intraoperative subanaesthetic esketamine on POD in this specific population.Methods and analysis This single-centre, randomised, double-blind, placebo-controlled trial will enrol 778 patients aged 60–80 years undergoing open-heart cardiovascular surgery in China, from September 2023 to December 2025. The participants will be randomly assigned in a 1:1 ratio to the following groups: the esketamine group and the control group. In the esketamine group, esketamine (2 mg/mL) will be administered intravenously at a dosage of 0.3 mg/kg over 10 min following tracheal intubation, followed by a continuous infusion at 0.15 mg/kg/h until the end of the surgery. Patients in the control group will receive a placebo following the same dosage and regimen. The incidence of POD will be the primary outcome and will be assessed twice daily from the first to the seventh postoperative day. The postoperative sleep quality, duration of postoperative mechanical ventilation, and length of hospital and intensive care unit stay will be the secondary outcomes.Ethics and dissemination Ethical approval was obtained from the Institutional Review Board of Fuwai Central China Cardiovascular Hospital (No. 2023068). Public disclosure is guaranteed post-trial, and the results will be published in a peer-reviewed scientific journal.Trial registration number ChiCTR2300074395.https://bmjopen.bmj.com/content/15/6/e089719.full |
| spellingShingle | Wei Zhang Liang Zhao Ju-Min Yan Qing-Ren Liu Jian-Jun Yang Hong-Qi Lin Zhao-Yu Wen Hao-Ran Zhang Yi-Xin Mei Rui-Di Wang Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China BMJ Open |
| title | Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China |
| title_full | Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China |
| title_fullStr | Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China |
| title_full_unstemmed | Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China |
| title_short | Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China |
| title_sort | efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery protocol for a single centre randomised double blind placebo controlled trial sepdoc trial in china |
| url | https://bmjopen.bmj.com/content/15/6/e089719.full |
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