Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol.
Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol.
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DOI：
10.1136/bmjopen-2021-051008
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发表时间：
2021-11-11
期刊：
影响因子：
2.9
通讯作者：
Mansjoer A
中科院分区：
文献类型：
--
作者：
Jaya AAGPS;Tantri AR;Heriwardito A;Mansjoer A
成人心内直视手术是一种大手术，会引起手术应激反应和免疫系统的激活，进一步增加术后并发症。胸横肌平面阻滞(TTPB)可能在减少手术应激反应方面有潜在的益处。本研究旨在了解成人心内直视手术术前应用TTPB对减少手术应激反应的效果。这项研究是一项前瞻性、双盲、随机对照试验，比较了成人心内直视手术中全身麻醉和TTPB联合麻醉与全身麻醉的效果。42名符合条件的受试者将被随机分配到城规会小组或对照组。主要结果是两组患者在心脏重症监护病房入院后24小时和48小时血浆皮质醇和白介素6水平的差异。次要结果是两组在术后24小时吗啡总消耗量和术后首次病人自控镇痛(PCA)剂量时间上的差异。印度尼西亚大学医学院伦理委员会/Cipto Mangunkusumo医生医院审查并批准了研究方案和知情同意书。研究结果将通过陈述和发表在同行评议的期刊上向医学界发布。NCT04544254。
Adult open-heart surgery is a major surgery that causes surgical stress response and activation of the immune system, contributing further to postoperative complications. Transversus thoracis muscle plane block (TTPB) may potentially benefit in reducing the surgical stress response. This study aims to know the effectiveness of preoperative TTPB in adult open-heart surgery for reducing the surgical stress response. This study is a prospective, double-blind, randomised control trial comparing the combination of general anaesthesia and TTPB versus general anaesthesia only in adult open-heart surgery. Forty-two eligible subjects will be randomly assigned to the TTPB group or control group. The primary outcomes are the difference between the two groups in the means of postoperative cortisol and interleukin-6 plasma levels at 24 hours and 48 hours after cardiac intensive care unit admission. The secondary outcomes are the difference between the two groups in the means of total 24-hour postoperative morphine consumption and time of first postoperative patient-controlled analgesia (PCA) dose. The study protocol and informed consent forms have been reviewed and approved by the Ethics Committee of Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo Hospital. The result will be released to the medical community through presentation and publication in peer-reviewed journals. NCT04544254.
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影响因子：
2.1
作者：
Saracevic, Andrea;Medved, Igor;Simundic, Ana-Maria
通讯作者：
Simundic, Ana-Maria
DOI：
10.1177/108925320500900109
发表时间：
2005-03-01
影响因子：
1.4
作者：
Djaiani, George;Fedorko, Ludwik;Beattie, W. Scott
通讯作者：
Beattie, W. Scott
DOI：
10.1016/j.bpa.2004.01.004
发表时间：
2004-09-01
期刊：
Best practice & research. Clinical anaesthesiology
影响因子：
--
作者：
Hahnenkamp, Klaus;Herroeder, Susanne;Hollmann, Markus W
通讯作者：
Hollmann, Markus W
DOI：
10.2478/v10046-012-0014-z
发表时间：
2012-01-01
期刊：
Proceedings of the Latvian Academy of Sciences Section B Natural Exact and Applied Sciences
影响因子：
--
作者：
Ivanovs, Igors;Mihelsons, Maris;Boka, Viesturs
通讯作者：
Boka, Viesturs
影响因子：
3.4
作者：
Gulielmos, V;Menschikowski, M;Schueler, S
通讯作者：
Schueler, S