Perioperative dexmedetomidine compared to midazolam in children undergoing open-heart surgery: A pilot randomised controlled trial

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2023-03-01 DOI:10.1016/j.ccrj.2023.04.007

Debbie A. Long RN, PhD , Kristen S. Gibbons PhD , Christian Stocker MD, FCICM , Michael Ranger MBCHB, FANZCA , Nelson Alphonso MD , Renate Le Marsney MPH , Belinda Dow BA(Psych)Hons, PhD , Jessica A. Schults RN, PhD , Cameron Graydon MBBS, FANZCA , Yahya Shehabi MBBS, PhD, FCICM, FANZCA , Andreas Schibler MD, FCICM

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引用次数: 0

Abstract

Objective

There is a need for evidence on the best sedative agents in children undergoing open heart surgery for congenital heart disease. This study aimed to evaluate the feasibility and safety of dexmedetomidine in this group compared with midazolam.

Design

Double blinded, pilot randomized controlled trial.

Setting

Cardiac operating theatre and paediatric intensive care unit in Brisbane, Australia.

Participants

Infants (≤12 months of age) undergoing their first surgical repair of a congenital heart defect.

Interventions

Dexmedetomidine (up to 1.0mcg/kg/hr) versus midazolam (up to 80mcg/kg/hr), commenced in the cardiac operating theatre prior to surgery.

Main outcome measures

The primary outcome was the time spent in light sedation (Sedation Behavior Scale [SBS] -1 to +1); Co-primary feasibility outcome was recruitment, retention and protocol adherence. Secondary outcomes were use of supplemental sedatives, ventilator free days, delirium, vasoactive drug support, and adverse events. Neurodevelopment and health-related quality of life (HRQoL) were assessed at 12 months post-surgery.

Results

Sixty-six participants were recruited. The number of SBS scores in the light sedation range were greater in the dexmedetomidine group at 24 hours, 48 hours, and overall study duration (0-14 days) versus the midazolam group (24hr: 76/170 [45%] vs 60/178 [34%], aOR 4.14 [95% CI 0.48, 35.92]; 48hr: 154/298 [52%] vs 122/314 [39%], aOR 6.95 [95% CI 0.77, 63.13]; 0-14 days: 597/831 [72%] vs 527/939 [56%], aOR 3.93 [95% CI 0.62, 25.03]). Feasibility was established with no withdrawals or loss to follow-up at 14 days and minimal protocol deviations. There were no differences between the groups relating to clinical, safety, neurodevelopment or HRQoL outcomes.

Conclusions

The use of dexmedetomidine was associated with more time spent in light sedation when compared with midazolam. The feasibility of conducting a blinded RCT of midazolam and dexmedetomidine in children undergoing open heart surgery was also established. The findings justify further investigation in a larger trial.

Clinical trial registration

ACTRN12615001304527.

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围手术期右美托咪定与咪达唑仑在儿童心内直视手术中的比较:一项随机对照试验

目的为先天性心脏病患儿行心脏直视手术的最佳镇静药物提供证据。本研究旨在评价右美托咪定与咪达唑仑在该组的可行性和安全性。设计双盲、随机对照试验。澳大利亚布里斯班的心脏手术室和儿科重症监护室。参与者:首次接受先天性心脏缺损手术修复的婴儿(≤12个月)。干预措施:术前在心脏手术室开始使用右美托咪定(最高1.0微克/千克/小时)与咪达唑仑(最高80微克/千克/小时)。主要观察指标:主要观察指标为轻度镇静时间(镇静行为量表[SBS] -1 ~ +1);共同的主要可行性结果是招募、保留和方案依从性。次要结局是补充镇静剂的使用、无呼吸机天数、谵妄、血管活性药物支持和不良事件。术后12个月评估神经发育和健康相关生活质量(HRQoL)。结果共招募66名参与者。右美托咪定组在24小时、48小时和总研究时间(0-14天)轻度镇静范围内的SBS评分数高于咪达唑仑组(24小时:76/170 [45%]vs 60/178 [34%]， aOR 4.14 [95% CI 0.48, 35.92];48小时:154/298 [52%]vs 122/314 [39%]， aOR为6.95 [95% CI 0.77, 63.13];0-14天:597/831 [72%]vs 527/939 [56%]， aOR 3.93 [95% CI 0.62, 25.03])。在14天无停药或随访损失和最小方案偏差的情况下，确立了可行性。两组之间在临床、安全性、神经发育或HRQoL结果方面没有差异。结论与咪达唑仑相比，右美托咪定的轻度镇静时间更长。在接受心脏直视手术的儿童中进行咪达唑仑和右美托咪定的盲法随机对照试验的可行性也得到了证实。这些发现证明了在更大的试验中进一步调查是合理的。临床试验注册actrn12615001304527。

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.