Early Sedation with Dexmedetomidine in Critically Ill Patients
Yahya Shehabi, Belinda D. Howe, Rinaldo Bellomo, et al
Abstract
BACKGROUND 背景
Dexmedetomidine produces sedation while maintaining a degree of arousability and may reduce the duration of mechanical ventilation and delirium among patients in the intensive care unit (ICU). The use of dexmedetomidine as the sole or primary sedative agent in patients undergoing mechanical ventilation has not been extensively studied.
右美托咪啶在镇静的同时，能够维持一定程度的觉醒，可能缩短ICU患者的机械通气及谵妄时间。对于接受机械通气的患者，使用右美托咪啶作为唯一或主要的镇静药物，尚没有深入的研究。
METHODS 方法
In an open-label, randomized trial, we enrolled critically ill adults who had been undergoing ventilation for less than 12 hours in the ICU and were expected to continue to receive ventilatory support for longer than the next calendar day to receive dexmedetomidine as the sole or primary sedative or to receive usual care (propofol, midazolam, or other sedatives). The target range of sedation-scores on the Richmond Agitation and Sedation Scale (which is scored from −5 [unresponsive] to +4 [combative]) was −2 to +1 (lightly sedated to restless). The primary outcome was the rate of death from any cause at 90 days.
这是一项开放标签，随机临床试验，入选患者包括那些在ICU接受机械通气不足12小时的成年危重病患者，且预计需要继续接受通气支持超过1天。患者分组包括使用右美托咪啶作为唯一或主要的镇静药物，或接受常规治疗（丙泊酚，咪达唑仑或其他镇静药物）。镇静评分采用RASS，镇静目标为-2到+1分（轻度镇静到不安焦虑）。主要预后指标为90天全因病死率。
RESULTS 结果
We enrolled 4000 patients at a median interval of 4.6 hours between eligibility and randomization. In a modified intention-to-treat analysis involving 3904 patients, the primary outcome event occurred in 566 of 1948 (29.1%) in the dexmedetomidine group and in 569 of 1956 (29.1%) in the usual-care group (adjusted risk difference, 0.0 percentage points; 95% confidence interval, −2.9 to 2.8). An ancillary finding was that to achieve the prescribed level of sedation, patients in the dexmedetomidine group received supplemental propofol (64% of patients), midazolam (3%), or both (7%) during the first 2 days after randomization; in the usual-care group, these drugs were administered as primary sedatives in 60%, 12%, and 20% of the patients, respectively. Bradycardia and hypotension were more common in the dexmedetomidine group.
我们入选了4000名患者，从满足入选标准到接受随机分组中位时间为4.6小时。修订后意向治疗分析纳入3904名患者，右美托咪啶组1948名患者中566人(29.1%)死亡，而常规治疗组1956名患者中569名(29.1%)死亡（校正后差异0.0 百分点；95%可信区间-2.9 to 2.8）。为达到镇静深度目标，随机分组后最初2天内，右美托咪啶组患者接受额外丙泊酚(64%)、咪达唑仑(3%)或两者均使用(7%)；常规治疗组患者上述药物作为主要镇静药物的比例分别为60%、12%和20%。右美托咪啶组心动过缓及低血压更为常见。
CONCLUSIONS 结论
Among patients undergoing mechanical ventilation in the ICU, those who received early dexmedetomidine for sedation had a rate of death at 90 days similar to that in the usual-care group and required supplemental sedatives to achieve the prescribed level of sedation. More adverse events were reported in the dexmedetomidine group than in the usual-care group. (Funded by the National Health and Medical Research Council of Australia and others; SPICE III ClinicalTrials.gov number, NCT01728558.)
对于接受机械通气的ICU患者，早期使用右美托咪啶进行镇静治疗达到所需镇静深度，其90天病死率与常规治疗相似。右美托咪啶组不良事件发生率高于常规治疗组。
