Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial).
Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial).
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比较右美托咪定与异丙酚对成人患者全身麻醉后苏醒期躁动的治疗效果：随机、优效性对照试验的研究方案（DP-TEA 试验）
DOI：
10.1186/s13063-021-05743-2
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发表时间：
2021-11-16
期刊：
影响因子：
2.5
通讯作者：
Zhang S
中科院分区：
文献类型：
--
作者：
Feng Z;Shi X;Yan X;Zhu Y;Gu J;Zhu H;Yu W;Zhang S
全身麻醉后苏醒期躁动 (EA) 是麻醉后监护室 (PACU) 的常见并发症。一旦发生 EA，目前还没有针对成人的治疗指南。异丙酚在 PACU 中过度使用来治疗躁动的患者，但它缺乏镇痛作用，可能导致呼吸暂停。术中输注右美托咪定已被证明对 EA 有预防作用，但右美托咪定对 EA 的治疗效果尚不清楚。本研究旨在比较右美托咪定和异丙酚在 PACU 全身麻醉后缓解成年患者 EA 的效果。在这项随机、优效、对照临床研究中，共有 120 名年龄在 18-65 岁的成年患者（男女不限，美国麻醉医师协会 (ASA) 分类 I 或 II，全身麻醉后在 PACU 中发生 EA）入组。患者将按 1:1 的比例随机分为两组，接受单剂量右美托咪定 (0.7μg/kg) 或异丙酚 (0.5mg/kg)。主要结局是 PACU 干预后 15 分钟内复发 EA 的患者比例。先前的研究主要集中在预防 EA 的术前用药，而缓解 EA 的治疗方法很少有报道。据我们所知，这项研究是第一个随机、优越性、对照试验，旨在比较右美托咪定推注与目前针对该适应症的常规护理。临床试验.govNCT04142840。注册日期：2019 年 10 月 26 日 在线版本包含可在 10.1186/s13063-021-05743-2 获取的补充材料。
Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propofol is excessively used in managing agitated patients in the PACU, but it lacks analgesia and can result in apnea. Intraoperative infusion of dexmedetomidine has been proven to have a preventive effect on EA, but the treatment effect of dexmedetomidine on EA remains unknown. This study aims to compare the effects between dexmedetomidine and propofol on relieving EA in adult patients after general anesthesia in the PACU. In this randomized, superiority, controlled clinical study, a total of 120 adult patients aged 18–65 years of both genders, with American Society of Anesthesiologists (ASA) classification I or II developing EA in the PACU after general anesthesia, will be enrolled. Patients will be randomized at a 1:1 ratio into two groups, receiving either a single dose of dexmedetomidine (0.7μg/kg) or propofol (0.5 mg/kg). The primary outcome is the proportion of patients having a recurrent EA within 15 min after intervention in the PACU. Previous studies have focused on premedication for preventing EA, while therapeutics for reliving EA have rarely been reported. To our knowledge, this study is the first randomized, superiority, controlled trial to compare a bolus of dexmedetomidine with the current routine care for this indication. ClinicalTrials.govNCT04142840. Registered on October 26, 2019 The online version contains supplementary material available at 10.1186/s13063-021-05743-2.
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