右美托咪定预防老年患者全凭静脉麻醉下行食管癌切除术后谵妄：一项双盲、随机临床试验。
Dexmedetomidine for prevention of postoperative delirium in older adults undergoing oesophagectomy with total intravenous anaesthesia: A double-blind, randomised clinical trial.
作者信息
Hu Jun, Zhu Mudan, Gao Zongbin, Zhao Shihao, Feng Xiaomei, Chen Jinbao, Zhang Ye, Maze Mervyn
机构信息
From the Department of Anaesthesiology, The Second Hospital of Anhui Medical University, and Key Laboratory of Anaesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, Anhui Medical University, Hefei (JH, YZ), Department of Anaesthesiology, Tongling People's Hospital of Anhui Medical University, Tongling, Anhui, China (MZ, ZG, SZ, JC), Department of Anaesthesiology, University of Utah, Salt Lake City, Utah (XF) and Department of Anaesthesia and Perioperative Care and Centre for Cerebrovascular Research, University of California, San Francisco, San Francisco, California, USA (XF, MM).
出版信息
Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S9-S17. doi: 10.1097/EJA.0000000000001382.
BACKGROUND
Dexmedetomidine is known to be a sedative. Recent studies suggest that administration of dexmedetomidine can prevent postoperative delirium (POD) which has been confirmed as a common complication after major surgery. However, its effects in patients undergoing oesophagectomy are scarce.
OBJECTIVE
To investigate the efficacy and safety of dexmedetomidine in reducing POD in elderly patients after transthoracic oesophagectomy with total intravenous anaesthesia (TIVA).
DESIGN
A randomised, double-blind, placebo-controlled trial.
SETTING
Single-centre, tertiary care hospital, November 2016 to September 2018.
PATIENTS
Eligible patients (n = 177) undergoing transthoracic oesophagectomy were randomly assigned to receive total intravenous anaesthesia (TIVA, n = 87) or dexmedetomidine with TIVA (DEX-TIVA, n = 90).
INTERVENTIONS
Patients receiving DEX-TIVA received a loading dose of dexmedetomidine (0.4 μg kg-1), over 15 min, followed by a continuous infusion at a rate of 0.1 μg kg-1 h-1 until 1 h before the end of surgery. Patients receiving TIVA received physiological saline with a similar infusion rate protocol.
OUTCOME MEASURES
The primary outcome was the incidence of POD. The secondary endpoints were the incidence of emergence agitation, serum interleukin-6 (IL-6) levels and haemodynamic profile.
RESULTS
All randomised patients were included with planned intention-to-treat analyses for POD. Delirium occurred in 15 (16.7%) of 90 cases given dexmedetomidine, and in 32 (36.8%) of 87 cases given saline (P = 0.0036). The DEX-TIVA group showed less frequent emergence agitation than the TIVA group (22.1 vs. 48.0%, P = 0.0058). The incremental change in surgery-induced IL-6 levels was greater in the TIVA group than DEX-TIVA group (P < 0.0001).
CONCLUSION
Adding peri-operative dexmedetomidine to a total intravenous anaesthetic safely reduces POD and emergence agitation in elderly patients undergoing open transthoracic oesophagectomy. These benefits were associated with a postoperative reduction in circulating levels of the pro-inflammatory cytokine IL-6 and stabilisation of the haemodynamic profile.
TRIAL REGISTRATION
Chinese Clinical Trials Register Identifier: ChiCTR-IPR-17010881.
背景
右美托咪定是一种镇静剂。近期研究表明，使用右美托咪定可预防术后谵妄（POD），术后谵妄已被确认为大手术后的常见并发症。然而，其在接受食管切除术患者中的作用尚少。
目的
探讨右美托咪定在降低老年患者经胸段食管切除全凭静脉麻醉（TIVA）后发生POD的有效性和安全性。
设计
一项随机、双盲、安慰剂对照试验。
地点
单中心三级护理医院，2016年11月至2018年9月。
患者
177例符合条件的接受经胸段食管切除术的患者被随机分配接受全凭静脉麻醉（TIVA组，n = 87）或右美托咪定联合全凭静脉麻醉（DEX-TIVA组，n = 90）。
干预措施
接受DEX-TIVA的患者静脉输注负荷剂量右美托咪定（0.4μg/kg），持续15分钟，随后以0.1μg·kg-1·h-1的速率持续输注直至手术结束前1小时。接受TIVA的患者以相似的输注速率方案输注生理盐水。
观察指标
主要观察指标为POD的发生率。次要终点为苏醒期躁动的发生率、血清白细胞介素-6（IL-6）水平和血流动力学指标。
结果
所有随机分组的患者均纳入POD的意向性分析。接受右美托咪定的90例患者中有15例（16.7%）发生谵妄，接受生理盐水的87例患者中有32例（36.8%）发生谵妄（P = 0.0036）。DEX-TIVA组苏醒期躁动的发生率低于TIVA组（22.1% 对48.0%，P = 0.0058）。手术诱导的IL-6水平的增量变化在TIVA组大于DEX-TIVA组（P < 0.0001）。
结论
在全凭静脉麻醉中加用围手术期右美托咪定可安全降低接受开放性经胸段食管切除术老年患者的POD和苏醒期躁动。这些益处与术后促炎细胞因子IL-6循环水平降低及血流动力学指标稳定有关。
试验注册
中国临床试验注册中心标识符：ChiCTR-IPR-17010881。
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