Bielka Kateryna, Kuchyn Iurii, Glumcher Felix
Department of Anesthesiology and Intensive Care, Bogomolets National Medical University, 13 T. Shevchenko Boulevard, 01601, Kiev, Ukraine.
Ann Intensive Care. 2015 Dec;5(1):33. doi: 10.1186/s13613-015-0075-7. Epub 2015 Nov 2.
Dexmedetomidine (DEX) is a centrally acting alpha-2-adrenoceptor agonist that has potential in the management of alcohol withdrawal syndrome (AWS) owing to its ability to produce arousable sedation and to inhibit the adrenergic system without respiratory depression. The objective of this randomized controlled study was to evaluate whether addition of DEX to benzodiazepine (BZD) therapy is effective and safe for AWS patients in the intensive care unit (ICU).
Eligible participants were randomly assigned to intervention (Group D; n = 36) or control (Group C; n = 36). In Group D, DEX infusion was started at a dose of 0.2-1.4 μg/kg/h and titrated to achieve the target sedation level (-2 to 0 on the Richmond Agitation Sedation Scale (RASS)) with symptom-triggered BZD (10 mg diazepam bolus) was used as needed. Patients in Group C received only symptom-triggered 10 mg boluses of diazepam. The primary efficacy outcomes were 24-h diazepam consumption and cumulative diazepam dose required over the course of the ICU stay; secondary outcomes included length of ICU stay, sedation and communication quality and haloperidol requirements.
Median 24-h diazepam consumption during the study was significantly lower in Group D (20 vs. 40 mg, p < 0.001), as well as median cumulative diazepam dose during the ICU stay (60 vs. 90 mg, p < 0.001). The median percentage of time in the target sedation range was higher in Group D (median 90 % (90-95) vs. 64.5 % (60-72.5; p < 0.001). DEX infusion was also associated with better nurse-assessed patient communication (<0.001) and fewer patients requiring haloperidol treatment (2 vs. 10 p = 0.02). One patient in Group D and four in Group C were excluded owing to insufficient control of AWS symptoms and use of additional sedatives (p = 0.36). There were no severe adverse events in either group. Spontaneous breathing remained normal in all patients. Bradycardia was a common adverse event in Group D (10 vs. 2; p = 0.03).
DEX significantly reduced diazepam requirements in ICU patients with AWS and decreased the number of patients who required haloperidol for severe agitation and hallucinations. DEX use was also associated with improvement in diverse aspects of sedation quality and the quality of patient communication.
ClinicalTrials.gov: NCT02496650.
右美托咪定(DEX)是一种中枢性作用的α2肾上腺素能受体激动剂,因其能够产生可唤醒的镇静作用并抑制肾上腺素能系统而无呼吸抑制,在酒精戒断综合征(AWS)的管理中具有潜力。这项随机对照研究的目的是评估在苯二氮䓬(BZD)治疗基础上加用DEX对重症监护病房(ICU)中AWS患者是否有效且安全。
符合条件的参与者被随机分配至干预组(D组;n = 36)或对照组(C组;n = 36)。在D组中,以0.2 - 1.4μg/kg/h的剂量开始输注DEX,并进行滴定以达到目标镇静水平(Richmond躁动镇静量表(RASS)评分为-2至0),必要时使用症状触发的BZD(10mg地西泮推注)。C组患者仅接受症状触发的10mg地西泮推注。主要疗效指标为24小时地西泮消耗量以及ICU住院期间所需的累积地西泮剂量;次要指标包括ICU住院时间、镇静和沟通质量以及氟哌啶醇的使用需求。
研究期间,D组24小时地西泮消耗量中位数显著低于C组(20mg对40mg,p < 0.001),ICU住院期间地西泮累积剂量中位数也较低(60mg对90mg,p < 0.001)。D组达到目标镇静范围的时间中位数百分比更高(中位数90%(90 - 95)对64.5%(60 - 72.5);p < 0.001)。输注DEX还与护士评估的患者沟通情况更好(<0.001)以及需要氟哌啶醇治疗的患者更少相关(2例对10例,p = 0.02)。由于AWS症状控制不足和使用了额外的镇静剂,D组有1例患者和C组有4例患者被排除(p = 0.36)。两组均未发生严重不良事件。所有患者的自主呼吸均保持正常。心动过缓是D组常见的不良事件(10例对2例;p = 0.03)。
DEX显著降低了ICU中AWS患者的地西泮需求量,并减少了因严重躁动和幻觉而需要氟哌啶醇治疗的患者数量。使用DEX还与镇静质量和患者沟通质量的多方面改善相关。
ClinicalTrials.gov:NCT02496650。