Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery.
Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery.
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一项随机对照临床试验的研究方案，比较地氟烷麻醉与丙泊酚麻醉对腹部大手术后阻塞性睡眠呼吸暂停患者麻醉后呼吸抑制的影响。
DOI：
10.1136/bmjopen-2021-051892
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发表时间：
2021-10-19
期刊：
影响因子：
2.9
通讯作者：
Hou L
中科院分区：
文献类型：
--
作者：
Wu H;Yang F;Zhang R;Xue H;Yang Y;Liao R;Li M;Wu X;Chen D;Chen G;Gong Y;Hou L
阻塞性睡眠呼吸暂停（OSA）患者对麻醉后呼吸抑制更为敏感。不同的麻醉方案（静脉麻醉为主还是吸入麻醉为主的全身麻醉）是否影响麻醉后呼吸抑制存在争议。尽管据报道地氟烷在包括OSA患者在内的特殊患者中具有良好的快速恢复特性，但关于其对麻醉后呼吸抑制有益的有力临床证据还远未揭示。本研究旨在通过调查腹部大手术后OSA患者在麻醉后恢复室（PACU）中地氟烷麻醉与丙泊酚麻醉相比的麻醉后呼吸抑制情况来填补这一知识空白。
854例计划进行择期腹部大手术的OSA患者将按照1∶1的比例，使用由集中随机化中心维护的计算机生成的随机分组方案（区组大小随机排列）随机分配接受地氟烷麻醉（n = 427）或丙泊酚麻醉（n = 427）。将根据标准化任务在手术前和术后连续3天对患者进行评估。在手术过程中收集人口统计学数据以及手术和麻醉信息。在给定的研究时间点评估PACU中麻醉后呼吸抑制的发生率以及麻醉恢复情况、苏醒期谵妄、术后恶心呕吐、补救性镇痛、PACU停留时间和住院时间以及任何其他不良事件。进行术后随访的研究人员不参与麻醉实施和术后护理。
本研究方案已获厦门大学翔安医院伦理委员会批准（XAHLL2019003）。本研究结果将发表在同行评审期刊上，并在全国性会议上以海报或口头报告的形式展示。希望了解本研究结果的参与者将在数据公布时直接得到联系。
ChiCTR2000031087（中国临床试验注册中心注册号）
Patients with obstructive sleep apnoea (OSA) are more sensitive to postanaesthesia respiratory depression. Whether different anaesthetic regimens (intravenous-based or inhalational-based general anaesthesia) affect the postanaesthesia respiratory depression is controversial. Although desflurane has been reported that presents favourable rapid recovery profile in special patients including whom with OSA, the strong clinical evidence of the benefit on postanaesthesia respiratory depression is far from being revealed. This study aims to fill this knowledge gap by investigating the postanaesthesia respiratory depression in postanaesthesia care unit (PACU) in patients with OSA after major abdominal surgery, followed by desflurane-based anaesthesia compared with propofol-based anaesthesia. Eight hundred and fifty-four patients with OSA scheduled for elective major abdominal surgery will be randomly 1:1 assigned to desflurane-based (n=427) or propofol-based anaesthesia (n=427) using a computer-generated randomisation scheme with permuted block size maintained by a centralised randomisation centre. Patients will be assessed before and a consecutive 3 days after their surgery according to the standardised tasks. Demographic data as well as surgical and anaesthesia information will be collected for the duration of the procedure. Incidence of postanaesthesia respiratory depression in PACU as well as anaesthesia recovery, emergence delirium, postoperative nausea and vomiting, rescue analgesia, duration of PACU and hospital stay, and any other adverse events will be assessed at the given study time point. Investigators performing postoperative follow-up are not involved in both anaesthesia implementation and postoperative care. This study protocol has been approved by the ethics board at Xiang’an Hospital of Xiamen University (XAHLL2019003). The results of this study will be published in a peer-review journal and presented at national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication. ChiCTR2000031087.
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DOI：
10.1164/rccm.201905-1071st
发表时间：
2019-08-01
影响因子：
24.7
作者：
Mokhlesi, Babak;Fernando Masa, Juan;Teodorescu, Mihaela
通讯作者：
Teodorescu, Mihaela
影响因子：
9.6
作者：
Mokhlesi, Babak;Hovda, Margaret D.;Meltzer, David O.
通讯作者：
Meltzer, David O.
气道阻塞性和缺氧事件的围手术期发生率是确认或疑似睡眠呼吸暂停的患者 - 一项前瞻性的，随机的试验研究，比较了丙泊酚/雷利芬太尼和Sevoflurane/sevoflurane/remifentanil麻醉。
影响因子：
2.2
作者：
Fassbender P;Bürgener S;Haddad A;Silvanus MT;Peters J
通讯作者：
Peters J
影响因子：
5.7
作者：
Chung F;Memtsoudis SG;Ramachandran SK;Nagappa M;Opperer M;Cozowicz C;Patrawala S;Lam D;Kumar A;Joshi GP;Fleetham J;Ayas N;Collop N;Doufas AG;Eikermann M;Englesakis M;Gali B;Gay P;Hernandez AV;Kaw R;Kezirian EJ;Malhotra A;Mokhlesi B;Parthasarathy S;Stierer T;Wappler F;Hillman DR;Auckley D
通讯作者：
Auckley D
影响因子：
2.2
作者：
Yu H;Zhang L;Ma Y;Yu H
通讯作者：
Yu H