Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study
Introduction Postoperative delirium (POD) is a notable complication in older adults undergoing major thoracic surgery and is associated with poor clinical outcomes. Ciprofol, an innovative sedative known for its haemodynamic stability, holds the potential to lower the risk of POD. However, high-qual...
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BMJ Publishing Group
2025-08-01
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| Series: | BMJ Open |
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| author | Li Wang Hao Wang Ailin Luo Qian Liu Wei Xiao E Wang Xiaoping Gu Wen Ouyang Tianlong Wang Pu Hong Shibiao Chen |
| author_facet | Li Wang Hao Wang Ailin Luo Qian Liu Wei Xiao E Wang Xiaoping Gu Wen Ouyang Tianlong Wang Pu Hong Shibiao Chen |
| author_sort | Li Wang |
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| description | Introduction Postoperative delirium (POD) is a notable complication in older adults undergoing major thoracic surgery and is associated with poor clinical outcomes. Ciprofol, an innovative sedative known for its haemodynamic stability, holds the potential to lower the risk of POD. However, high-quality evidence supporting this claim is limited. The objective of this study is to evaluate the effect of ciprofol compared with propofol on the incidence of POD and postoperative outcomes in older patients undergoing thoracic surgeries.Methods and analysis This multicentre, prospective, single-blinded, randomised controlled trial will recruit patients aged ≥65 years scheduled for elective thoracoscopic lobectomy or segmentectomy, with an anticipated anaesthesia duration of at least 2 hours. Participants will be randomised to receive either ciprofol (0.25–1.5 mg/kg/hour) or propofol (1–6 mg/kg/hour) in a 1:1 ratio. The primary outcome is the incidence of POD within 7 days postoperatively, assessed via the three-dimensional confusion assessment method. Secondary outcomes include emergence delirium assessed using the confusion assessment method for the intensive care unit, the incidence of combined adverse events during induction and maintenance of anaesthesia, duration of intraoperative hypotension, minimum mean intraoperative arterial pressure, duration of Wavelet Index <40, other adverse events identified during the follow-up period, length of stay, first exhaust time and postoperative first time to taking food. A non-inferiority margin of 5% is applied for sample size calculation, yielding a total of 214 participants, adjusted for a 10% attrition rate.Ethics and dissemination Approval on ethical grounds has been received from the ethics committee of Xuanwu Hospital, Capital Medical University (LinYanShen (2024)-NO.201–003-Revised V.1). We will publish the findings in peer-reviewed journals.Trial registration number NCT06674226. |
| format | Article |
| id | doaj-art-046aa0ce8dce46518e859a36a5dbd91b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-046aa0ce8dce46518e859a36a5dbd91b2025-08-20T03:50:24ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2025-105818Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled studyLi Wang0Hao Wang1Ailin Luo2Qian Liu3Wei Xiao4E Wang5Xiaoping Gu6Wen Ouyang7Tianlong Wang8Pu Hong9Shibiao Chen107 Department of Anesthesiology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China9 Department of Anesthesiology, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China4 Department of Anesthesiology, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China1 Department of Anesthesiology, Xuanwu Hospital Capital Medical University, Beijing, Beijing, China1 Department of Anesthesiology, Xuanwu Hospital Capital Medical University, Beijing, Beijing, China5 Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China6 Department of Anesthesiology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China3 Department of Anesthesiology, Third Xiangya Hospital of Central South University, Changsha, Hunan, China1 Department of Anesthesiology, Xuanwu Hospital Capital Medical University, Beijing, Beijing, China1 Department of Anesthesiology, Xuanwu Hospital Capital Medical University, Beijing, Beijing, China8 Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, ChinaIntroduction Postoperative delirium (POD) is a notable complication in older adults undergoing major thoracic surgery and is associated with poor clinical outcomes. Ciprofol, an innovative sedative known for its haemodynamic stability, holds the potential to lower the risk of POD. However, high-quality evidence supporting this claim is limited. The objective of this study is to evaluate the effect of ciprofol compared with propofol on the incidence of POD and postoperative outcomes in older patients undergoing thoracic surgeries.Methods and analysis This multicentre, prospective, single-blinded, randomised controlled trial will recruit patients aged ≥65 years scheduled for elective thoracoscopic lobectomy or segmentectomy, with an anticipated anaesthesia duration of at least 2 hours. Participants will be randomised to receive either ciprofol (0.25–1.5 mg/kg/hour) or propofol (1–6 mg/kg/hour) in a 1:1 ratio. The primary outcome is the incidence of POD within 7 days postoperatively, assessed via the three-dimensional confusion assessment method. Secondary outcomes include emergence delirium assessed using the confusion assessment method for the intensive care unit, the incidence of combined adverse events during induction and maintenance of anaesthesia, duration of intraoperative hypotension, minimum mean intraoperative arterial pressure, duration of Wavelet Index <40, other adverse events identified during the follow-up period, length of stay, first exhaust time and postoperative first time to taking food. A non-inferiority margin of 5% is applied for sample size calculation, yielding a total of 214 participants, adjusted for a 10% attrition rate.Ethics and dissemination Approval on ethical grounds has been received from the ethics committee of Xuanwu Hospital, Capital Medical University (LinYanShen (2024)-NO.201–003-Revised V.1). We will publish the findings in peer-reviewed journals.Trial registration number NCT06674226.https://bmjopen.bmj.com/content/15/8/e105818.full |
| spellingShingle | Li Wang Hao Wang Ailin Luo Qian Liu Wei Xiao E Wang Xiaoping Gu Wen Ouyang Tianlong Wang Pu Hong Shibiao Chen Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study BMJ Open |
| title | Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study |
| title_full | Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study |
| title_fullStr | Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study |
| title_full_unstemmed | Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study |
| title_short | Effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery: protocol for a multicentre, prospective, single-blinded, randomised controlled study |
| title_sort | effects of ciprofol on postoperative delirium and outcomes in older patients undergoing major thoracic surgery protocol for a multicentre prospective single blinded randomised controlled study |
| url | https://bmjopen.bmj.com/content/15/8/e105818.full |
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