Department of Anaesthesiology, Critical Care and Pain Medicine, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.
Trials. 2011 Jul 6;12:170. doi: 10.1186/1745-6215-12-170.
Postoperative delirium can result in increased postoperative morbidity and mortality, major demand for postoperative care and higher hospital costs. Hypnotics serve to induce and maintain anaesthesia and to abolish patients' consciousness. Their persisting clinical action can delay postoperative cognitive recovery and favour postoperative delirium. Some evidence suggests that these unwanted effects vary according to each hypnotic's specific pharmacodynamic and pharmacokinetic characteristics and its interaction with the individual patient.We designed this study to evaluate postoperative delirium rate after general anaesthesia with various hypnotics in patients undergoing surgical procedures other than cardiac or brain surgery. We also aimed to test whether delayed postoperative cognitive recovery increases the risk of postoperative delirium.
METHODS/DESIGN: After local ethics committee approval, enrolled patients will be randomly assigned to one of three treatment groups. In all patients anaesthesia will be induced with propofol and fentanyl, and maintained with the anaesthetics desflurane, or sevoflurane, or propofol and the analgesic opioid fentanyl.The onset of postoperative delirium will be monitored with the Nursing Delirium Scale every three hours up to 72 hours post anaesthesia. Cognitive function will be evaluated with two cognitive test batteries (the Short Memory Orientation Memory Concentration Test and the Rancho Los Amigos Scale) preoperatively, at baseline, and postoperatively at 20, 40 and 60 min after extubation.Statistical analysis will investigate differences in the hypnotics used to maintain anaesthesia and the odds ratios for postoperative delirium, the relation of early postoperative cognitive recovery and postoperative delirium rate. A subgroup analysis will be used to categorize patients according to demographic variables relevant to the risk of postoperative delirium (age, sex, body weight) and to the preoperative score index for delirium.
The results of this comparative anaesthesiological trial should whether each the three hypnotics tested is related to a significantly different postoperative delirium rate. This information could ultimately allow us to select the most appropriate hypnotic to maintain anaesthesia for specific subgroups of patients and especially for those at high risk of postoperative delirium. REGISTERED AT TRIAL.GOV NUMBER: ClinicalTrials.gov: NCT00507195.
术后谵妄可导致术后发病率和死亡率增加、对术后护理的大量需求以及更高的住院费用。催眠药物可用于诱导和维持麻醉，并消除患者的意识。它们持续的临床作用可能会延迟术后认知恢复并有利于术后谵妄。一些证据表明，这些不良影响因每种催眠药物的特定药效学和药代动力学特征及其与个体患者的相互作用而有所不同。我们设计了这项研究，以评估接受非心脏或脑部手术的患者在全身麻醉下使用各种催眠药物后的术后谵妄发生率。我们还旨在测试术后认知恢复延迟是否会增加术后谵妄的风险。
方法/设计：在获得当地伦理委员会批准后，纳入的患者将被随机分配到三个治疗组之一。在所有患者中，麻醉将使用异丙酚和芬太尼诱导，并使用麻醉剂地氟烷、七氟醚或异丙酚和阿片类镇痛药芬太尼维持。术后谵妄将使用护理谵妄量表每 3 小时监测一次，直到麻醉后 72 小时。认知功能将使用两个认知测试包（短期记忆定向记忆浓度测试和拉霍亚洛马斯康复量表）进行评估，术前、基线时以及术后拔管后 20、40 和 60 分钟。统计分析将调查用于维持麻醉的催眠药物之间的差异以及术后谵妄的优势比、早期术后认知恢复与术后谵妄发生率的关系。亚组分析将用于根据与术后谵妄风险相关的人口统计学变量（年龄、性别、体重）和术前谵妄评分指数对患者进行分类。
这项比较麻醉学试验的结果应该确定测试的三种催眠药物中的每一种是否与明显不同的术后谵妄发生率相关。这些信息最终可以帮助我们为特定亚组患者选择最合适的催眠药物来维持麻醉，特别是对于那些术后谵妄风险较高的患者。在 ClinicalTrials.gov 注册：ClinicalTrials.gov：NCT00507195。
