Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris, F-92700, Colombes, France.
Epidémiologie Clinique et Évaluation Économique Appliqué aux Populations Vulnérables (ECEVE), UMR 1123, Université Paris Diderot, Sorbonne Paris Cité, F-75018, Paris, France.
Crit Care. 2017 Sep 6;21(1):235. doi: 10.1186/s13054-017-1822-y.
Weaning from mechanical ventilation (MV) may be impeded by the occurrence of agitation. Loxapine has the ability to control agitation without affecting spontaneous ventilation. The aim of this study was to establish whether loxapine would reduce MV weaning duration in agitated patients.
We performed a multicentre, double-blind, placebo-controlled, parallel group, randomised trial. Patients who were potential candidates for weaning but exhibited agitation (Richmond Agitation-Sedation Scale score ≥ 2) after sedation withdrawal were randomly assigned to receive either loxapine or placebo. In case of severe agitation, conventional sedation was immediately resumed. The primary endpoint was the time between first administration of loxapine or placebo and successful extubation.
The trial was discontinued after 102 patients were enrolled because of an insufficient inclusion rate. Median times to successful extubation were 3.2 days in the loxapine group and 5 days in the placebo group (relative risk 1.2, 95% CI 0.75-1.88, p = 0.45). During the first 24 h, sedation was more frequently resumed in the placebo group (44% vs 17%, p = 0.01).
In this prematurely stopped trial, loxapine did not significantly shorten weaning from MV. However, loxapine reduced the need for resuming sedation.
Clinicaltrials.gov, NCT01193816 . Registered on 26 August 2010.
机械通气（MV）的脱机可能会因出现激越而受阻。洛沙平具有控制激越而不影响自主通气的能力。本研究旨在确定洛沙平是否会缩短激越患者的 MV 脱机时间。
我们进行了一项多中心、双盲、安慰剂对照、平行组、随机试验。在镇静撤药后出现躁动（Richmond 躁动-镇静量表评分≥2）但有脱机潜力的患者被随机分配接受洛沙平或安慰剂治疗。在出现严重躁动的情况下，立即重新开始常规镇静。主要终点是首次给予洛沙平或安慰剂与成功拔管之间的时间。
由于纳入率低，该试验在 102 例患者入组后被中止。洛沙平组成功拔管的中位时间为 3.2 天，安慰剂组为 5 天（相对风险 1.2，95%CI 0.75-1.88，p=0.45）。在最初的 24 小时内，安慰剂组更频繁地重新开始镇静（44% vs 17%，p=0.01）。
在这项提前停止的试验中，洛沙平并未显著缩短 MV 脱机时间。然而，洛沙平减少了恢复镇静的需要。
Clinicaltrials.gov，NCT01193816。于 2010 年 8 月 26 日注册。
