Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial.
Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial.
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依托咪酯与异丙酚全静脉麻醉对老年患者主要术后并发症的影响：一项随机临床试验。
DOI：
10.1001/jamasurg.2022.3338
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发表时间：
2022-10-01
期刊：
影响因子：
16.9
通讯作者：
中科院分区：
文献类型：
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作者：
本随机临床试验比较了在中国老年患者腹部手术中使用依托咪酯与丙泊酚的院内发病率、临床结局和死亡率。依托咪酯用于老年腹部手术患者全麻诱导和维持时，与丙泊酚相比，对院内发病率的影响是否非劣效？在这项随机临床试验中，1944例接受择期腹部手术的老年患者中，依托咪酯和丙泊酚全麻患者的主要院内并发症发生率非劣效于依托咪酯和丙泊酚（9.3% vs 8.7%）。本试验的结果表明，依托咪酯麻醉与丙泊酚相比不会增加老年患者的术后发病率。老年患者可能受益于依托咪酯全身麻醉的血流动力学稳定性。然而，依托咪酯抑制肾上腺皮质功能的可能性是否会增加发病率仍不确定。验证依托咪酯与丙泊酚麻醉不会增加老年患者腹部手术后院内发病率的主要假设。本项多中心、平行组、非劣效性随机临床试验（依托咪酯vs丙泊酚治疗院内并发症[EPIC]）于2017年8月15日至2020年11月20日在中国22家三级医院进行。参与者年龄在65至80岁之间，计划进行择期腹部手术。患者和结局评估者对组分配不知情。数据分析遵循改良的意向治疗原则。患者按1：1的比例随机接受依托咪酯或丙泊酚靶控输注进行全身麻醉。主要结局是主要院内术后并发症的复合终点（非劣效性界值为3%）。次要结局包括术中血流动力学测量;术后肾上腺皮质激素水平;自我报告的术后疼痛、恶心和呕吐;以及术后6个月和12个月的死亡率。共有1944名受试者接受了随机化，其中1917名（98.6%）完成了试验。患者被随机分配至依托咪酯组（n = 967;平均[SD]年龄，70.3 [4.0]岁; 578例男性[59.8%]）或丙泊酚组（n = 950;平均[SD]年龄，70.6 [4.2]岁; 533例男性[56.1%]）。依托咪酯组967例患者中有90例（9.3%）发生主要终点，丙泊酚组950例患者中有83例（8.7%）发生主要终点，符合非劣效性标准（风险差[RD]，0.6%; 95%CI，-1.6%至2.7%; P = 0.66）。在依托咪酯组，手术结束时平均（SD）皮质醇水平较低（4.8 [2.7] μ g/dL vs 6.1 [3.4] μ g/dL; P <.001），手术结束时平均（SD）醛固酮水平较低（0.13 [0.05] ng/dL vs 0.15 [0.07] ng/dL; P =.02）和术后第1天（0.14 [0.04] ng/dL vs 0.16 [0.06] ng/dL; P =.001）与丙泊酚组相比。术后6个月（2.2% vs 3.0%; RD，-0.8%; 95% CI，-2.2%至0.7%）和12个月（3.3% vs 3.9%; RD，-0.6%; 95% CI，-2.3%至1.0%），依托咪酯组和丙泊酚组之间的死亡率无差异。依托咪酯组发生肺炎的患者多于丙泊酚组（2.0% vs 0.3%; RD，1.7%; 95% CI，0.7%-2.8%; P = 0.001）。符合方案人群的结果一致。本试验的结果表明，与丙泊酚相比，依托咪酯麻醉不会增加老年患者腹部手术后的总体主要住院发病率，尽管它会引起短暂的肾上腺皮质抑制。ClinicalTrials.gov
This randomized clinical trial compares the in-hospital morbidity, clinical outcomes, and mortality associated with use of etomidate vs propofol during abdominal surgery in older patients in China. Does etomidate compared with propofol provide a noninferior effect on in-hospital morbidity when used for induction and maintenance of general anesthesia in older patients undergoing abdominal surgery? In this randomized clinical trial involving 1944 older patients who underwent elective abdominal surgery, the rate of major in-hospital complications was noninferior between patients who received etomidate and those who received propofol for general anesthesia (9.3% vs 8.7%). Findings of this trial indicate that etomidate anesthesia does not increase postoperative morbidity in older patients compared with propofol. 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. To test the primary hypothesis that etomidate vs propofol for anesthesia does not increase in-hospital morbidity after abdominal surgery in older patients. 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. Patients were randomized 1:1 to receive either etomidate or propofol for general anesthesia by target-controlled infusion. 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. 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] μg/dL vs 6.1 [3.4] μg/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 (3.3% 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. 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. ClinicalTrials.gov Identifier: NCT02910206
影响因子：
3.9
作者：
Weiss B;Schiefenhövel F;Grunow JJ;Krüger M;Spies CD;Menk M;Kruppa J;Grubitzsch H;Sander M;Treskatsch S;Balzer F
通讯作者：
Balzer F
DOI：
10.7759/cureus.13445
发表时间：
2021-02-19
期刊：
Cureus
影响因子：
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作者：
Cagliani JA;Ruhemann A;Molmenti E;Smith C;Coppa G;Barrera R
通讯作者：
Barrera R