前瞻性、随机、双盲、双模拟、阳性药物对照、3 期临床试验比较鼻内右美托咪定与口服咪达唑仑作为小儿患者磁共振成像检查中异丙酚镇静的预用药的安全性和有效性：MIDEX MRI 试验。
Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging: the MIDEX MRI trial.
机构信息
Department of Anesthesiology, Hôpital Universitaire de Bruxelles - Hôpital universitaire des enfants Reine Fabiola, Brussels, Belgium.
Université Libre de Bruxelles, Brussels, Belgium.
出版信息
Trials. 2023 Aug 11;24(1):518. doi: 10.1186/s13063-023-07529-0.
BACKGROUND
Children under 6 years who need magnetic resonance imaging usually require sedation to obtain best quality images, but the optimal sedation protocol remains to be determined. In 2018, we showed a 22% interruption in image acquisition during magnetic resonance imaging when performing a propofol-based sedation using a bolus approach. As non-pharmacological premedication is often insufficient to reduce the anxiety of children related to parental separation, pharmacological premedication may be useful to facilitate the induction of anesthesia. In our institution, effective premedication is obtained oral intake of midazolam, though its administration relies on patients' compliance and could also lead to paradoxical reaction. Dexmedetomidine has a safe profile in the pediatric population and can therefore represent an interesting alternative. The primary objective of this trial is to demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in reducing the occurrence of any event requiring temporary or definitive interruption of the examination to allow anesthesiologist intervention in children undergoing magnetic resonance imaging under propofol sedation.
METHODS
In this single-center, prospective, randomized, double-blind, double-dummy, active comparator-controlled, superiority trial, we planned to include 250 patients, aged 6 months to 6 years, undergoing a scheduled magnetic resonance imaging requiring the presence of an anesthesiologist. After informed consent, the patients will be randomized to receive either oral midazolam or intranasal dexmedetomidine as premedication. The data will be analyzed in intention to treat, using Kolmogorov-Smirnov Z, chi-square, Wilcoxon, and Mann-Whitney U tests. A P-value < 0.05 will be considered statistically significant.
DISCUSSION
The MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period.
TRIAL REGISTRATION
ClinicalTrial.gov NCT05192629 . Registered on 14 January 2022. Protocol version 2.1.
背景
6 岁以下需要磁共振成像的儿童通常需要镇静以获得最佳质量的图像，但最佳镇静方案仍有待确定。2018 年，我们发现使用依托咪酯进行镇静时，采用推注法进行镇静时，磁共振成像过程中图像采集中断率为 22%。由于非药物性预给药通常不足以减轻儿童与父母分离相关的焦虑，因此药物性预给药可能有助于促进麻醉诱导。在我们的机构中，有效的预给药是通过口服咪达唑仑来实现的，尽管其给药依赖于患者的依从性，并且也可能导致矛盾反应。右美托咪定在儿科人群中的安全性良好，因此可以作为一种有吸引力的替代药物。本试验的主要目的是证明与口服咪达唑仑相比，鼻内给予右美托咪定作为依托咪酯镇静前的预给药，可降低任何需要暂时或永久中断检查以允许麻醉师干预的事件的发生率，从而允许在接受依托咪酯镇静的儿童中进行磁共振成像。
方法
在这项单中心、前瞻性、随机、双盲、双模拟、阳性对照、优效性试验中，我们计划纳入 250 名年龄在 6 个月至 6 岁之间、需要麻醉师在场的计划行磁共振成像的患者。在获得知情同意后，患者将被随机分为口服咪达唑仑或鼻内给予右美托咪定作为预给药。将采用 Kolmogorov-Smirnov Z、卡方、Wilcoxon 和 Mann-Whitney U 检验进行意向治疗分析。P 值<0.05 被认为具有统计学意义。
讨论
MIDEX MRI 研究将评估鼻内给予右美托咪定与口服咪达唑仑相比，在不影响术后期间的情况下，在进行依托咪酯镇静之前，对改善磁共振成像质量的疗效。
试验注册
ClinicalTrials.gov NCT05192629。于 2022 年 1 月 14 日注册。方案版本 2.1。
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