Department of Anesthesia and Critical Care, Rouen University Hospital, Rouen, France
U1096, INSERM, Rouen, France.
BMJ Open. 2024 Jun 3;14(6):e079984. doi: 10.1136/bmjopen-2023-079984.
Intraoperative opioids have been used for decades to reduce negative responses to nociception. However, opioids may have several, and sometimes serious, adverse effects. Cardiac surgery exposes patients to a high risk of postoperative complications, some of which are common to those caused by opioids: acute respiratory failure, postoperative cognitive dysfunction, postoperative ileus (POI) or death. An opioid-free anaesthesia (OFA) strategy, based on the use of dexmedetomidine and lidocaine, may limit these adverse effects, but no randomised trials on this issue have been published in cardiac surgery.We hypothesised that OFA versus opioid-based anaesthesia (OBA) may reduce the incidence of major opioid-related complications after cardiac surgery.
Multicentre, randomised, parallel and single-blinded clinical trial in four cardiac surgical centres in France, including 268 patients scheduled for coronary artery bypass grafting under cardiac bypass, with or without aortic valve replacement. Patients will be randomised to either a control OBA protocol using remifentanil or an OFA protocol using dexmedetomidine/lidocaine. The primary composite endpoint is the occurrence of at least one of the following: (1) postoperative cognitive disorder evaluated by the Confusion Assessment Method for the Intensive Care Unit test, (2) POI, (3) acute respiratory distress or (4) death within the first 48 postoperative hours. Secondary endpoints are postoperative pain, morphine consumption, nausea-vomiting, shock, acute kidney injury, atrioventricular block, pneumonia and length of hospital stay.
This trial has been approved by an independent ethics committee ( on 23 February 2021). Results will be submitted in international journals for peer reviewing.
NCT04940689, EudraCT 2020-002126-90.
几十年来，术中阿片类药物一直被用于减轻对伤害感受的负面反应。然而，阿片类药物可能有几个，有时是严重的，不良影响。心脏手术使患者面临术后并发症的高风险，其中一些与阿片类药物引起的并发症相同：急性呼吸衰竭、术后认知功能障碍、术后肠梗阻（POI）或死亡。基于右美托咪定和利多卡因使用的无阿片类麻醉（OFA）策略可能会限制这些不良反应，但在心脏手术中尚未发表关于该问题的随机试验。我们假设 OFA 与基于阿片类药物的麻醉（OBA）相比，可能会降低心脏手术后主要与阿片类药物相关的并发症的发生率。
法国四个心脏外科中心的多中心、随机、平行和单盲临床试验，包括 268 例接受体外循环下冠状动脉旁路移植术（CABG）的患者，其中包括或不包括主动脉瓣置换术。患者将随机分为接受使用瑞芬太尼的对照 OBA 方案或使用右美托咪定/利多卡因的 OFA 方案。主要复合终点是以下至少一种情况的发生：（1）通过重症监护病房意识模糊评估法（CAM-ICU）评估的术后认知障碍，（2）POI，（3）急性呼吸窘迫，或（4）术后 48 小时内死亡。次要终点是术后疼痛、吗啡消耗量、恶心呕吐、休克、急性肾损伤、房室传导阻滞、肺炎和住院时间。
该试验已获得独立伦理委员会的批准（2021 年 2 月 23 日）。结果将提交给国际期刊进行同行评审。
NCT04940689，EudraCT 2020-002126-90。
