机构:[1]Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.[2]Department of Anesthesiology, The First Affiliated Hospital of Xinjiang Medical University, Urumuqi, Xinjiang, China.[3]Department of Anesthesiology, Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China.[4]Department of Anesthesiology, ZhuJiang Hospital of Southern Medical University, Guangzhou, Guangdong, China.南方医科大学珠江医院[5]Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.[6]Department of Anesthesiology, Chinese PLA General Hospital, Peking, China.[7]Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Peking, China.外科系统麻醉手术科首都医科大学宣武医院[8]Department of Anesthesiology, Anhui Provincial Hospital, University of Science and Technology of China, Hefei, Anhui, China.[9]Department of Anesthesiology, Xiangya Hospital of Central South University, Changsha, Hunan, China.[10]Department of Anesthesiology, Xuzhou Central Hospital, Southeast University, Xuzhou, Jiangsu, China.[11]Department of Anesthesiology, Tianjin Medical University General Hospital, Tianjin, China.[12]Department of Anesthesiology, Fujian Provincial Hospital, Fuzhou, Fujian, China.[13]Department of Anesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.[14]Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.[15]Department of Anesthesiology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.[16]Department of Anesthesiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.[17]Department of Anesthesiology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking, China.[18]Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.中山大学附属第一医院[19]Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Peking, China.北京朝阳医院[20]Department of Anesthesiology, Changhai Hospital, Navy Medical University, Shanghai, China.[21]Department of Anesthesiology, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China.[22]Department of Anesthesiology, Kunming General Hospital of Chengdu Military Region, Kunming, Yunnan, China.[23]Research Center of Clinical Epidemiology, Peking University Third Hospital, Peking, China.[24]Translational Research Institute of Brain and Brain-Like Intelligence and Department of Anesthesiology and Perioperative Medicine, Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine, Shanghai, China.
IMPORTANCE Older patients may benefit from the hemodynamic stability of etomidate for general anesthesia. However, it remains uncertain whether the potential for adrenocortical suppression with etomidate may increase morbidity. OBJECTIVE To test the primary hypothesis that etomidate vs propofol for anesthesia does not increase in-hospital morbidity after abdominal surgery in older patients. DESIGN, SETTING, AND PARTICIPANTS This multicenter, parallel-group, noninferiority randomized clinical trial (Etomidate vs Propofol for In-hospital Complications [EPIC]) was conducted between August 15, 2017, and November 20.2020, at 22 tertiary hospitals in China. Participants were aged 65 to 80 years and were scheduled for elective abdominal surgery. Patients and outcome assessors were blinded to group allocation. Data analysis followed a modified intention-to-treat principle. INTERVENTIONS Patients were randomized 1:1 to receive either etomidate or propofol for general anesthesia by target-controlled infusion. MAIN OUTCOMES AND MEASURES Primary outcome was a composite of major in-hospital postoperative complications (with a noninferiority margin of 3%). Secondary outcomes included intraoperative hemodynamic measurements; postoperative adrenocortical hormone levels; self-reported postoperative pain, nausea, and vomiting; and mortality at postoperative months 6 and 12. RESULTS A total of 1944 participants were randomized, of whom 1917 (98.6%) completed the trial. Patients were randomized to the etomidate group (n = 967; mean [SD] age, 70.3 [4.0] years; 578 men [59.8%]) or propofol group (n = 950; mean [SD] age, 70.6 [4.2] years; 533 men [56.1%]). The primary end point occurred in 90 of 967 patients (9.3%) in the etomidate group and 83 of 950 patients (8.7%) in the propofol group, which met the noninferiority criterion (risk difference [RD], 0.6%: 95% CI. -1.6% to 2.7%; P = .66). In the etomidate group, mean (SD) cortisol levels were lower at the end of surgery (4.8 [2.7] mu g/dL vs 6.1[3.4] mu g/dL; P < .001) and mean (SD) aldosterone levels were lower at the end of surgery (0.13 [0.05] ng/dL vs 0.15 [0.07] ng/dL; P = .02) and on postoperative day 1(0.14 [0.04] ng/dL vs 0.16 [0.06] ng/dL; P = .001) compared with the propofol group. No difference in mortality was observed between the etomidate and propofol groups at postoperative month 6 (2.2% vs 3.0%; RD, -0.8%; 95% CI, -2.2% to 0.7%) and 12 (33% vs 3.9%; RD, -0.6%; 95% CI, -2.3% to 1.0%). More patients had pneumonia in the etomidate group than in the propofol group (2.0% vs 0.3%; RD. 1.7%; 95% CI. 0.7% to 2.8%; P = .001). Results were consistent in the per-protocol population. CONCLUSIONS AND RELEVANCE Results of this trial showed that, compared with propofol, etomidate anesthesia did not increase overall major in-hospital morbidity after abdominal surgery in older patients, although it induced transient adrenocortical suppression.
基金:
National Natural Science Foundation of China [82030038, 81871028, 81871023]
第一作者机构:[1]Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
通讯作者:
通讯机构:[1]Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.[24]Translational Research Institute of Brain and Brain-Like Intelligence and Department of Anesthesiology and Perioperative Medicine, Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine, Shanghai, China.[*1]Translational Research Institute of Brain and Brain-Like Intelligence and Department of Anesthesiology and Perioperative Medicine, Shanghai Fourth People’s Hospital Affiliated to Tongji University School of Medicine, Shanghai 200434, China[*2]Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Fourth Military Medical University, ChangleWest Rd 127, Xi’an, Shaanxi 710032, China
推荐引用方式(GB/T 7714):
Lu Zhihong,Zheng Hong,Chen Zhijun,et al.Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients A Randomized Clinical Trial[J].JAMA SURGERY.2022,157(10):888-895.doi:10.1001/jamasurg.2022.3338.
APA:
Lu, Zhihong,Zheng, Hong,Chen, Zhijun,Xu, Shiyuan,Chen, Shibiao...&Xiong, Lize.(2022).Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients A Randomized Clinical Trial.JAMA SURGERY,157,(10)
MLA:
Lu, Zhihong,et al."Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients A Randomized Clinical Trial".JAMA SURGERY 157..10(2022):888-895