Long Debbie A, Gibbons Kristen S, Stocker Christian, Ranger Michael, Alphonso Nelson, Le Marsney Renate, Dow Belinda, Schults Jessica A, Graydon Cameron, Shehabi Yahya, Schibler Andreas
School of Nursing, Centre for Healthcare Transformation, Queensland University of Technology, Australia.
Paediatric Intensive Care Unit, Queensland Children's Hospital, Australia.
Crit Care Resusc. 2023 May 20;25(1):33-42. doi: 10.1016/j.ccrj.2023.04.007. eCollection 2023 Mar.
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.
Double blinded, pilot randomized controlled trial.
Cardiac operating theatre and paediatric intensive care unit in Brisbane, Australia.
Infants (≤12 months of age) undergoing their first surgical repair of a congenital heart defect.
Dexmedetomidine (up to 1.0mcg/kg/hr) versus midazolam (up to 80mcg/kg/hr), commenced in the cardiac operating theatre prior to surgery.
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.
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.
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.
ACTRN12615001304527.
对于先天性心脏病患儿接受心脏直视手术时最佳镇静药物，需要有相关证据。本研究旨在评估右美托咪定与咪达唑仑相比，在该组患儿中的可行性和安全性。
双盲、试点随机对照试验。
澳大利亚布里斯班的心脏手术室和儿科重症监护病房。
首次接受先天性心脏缺陷手术修复的婴儿（≤12个月龄）。
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），在手术前于心脏手术室开始使用。
主要结局是轻度镇静状态下的时长（镇静行为量表[SBS]-1至+1）；共同主要可行性结局是招募、留存率和方案依从性。次要结局是补充镇静剂的使用、无呼吸机天数、谵妄、血管活性药物支持及不良事件。术后12个月评估神经发育和健康相关生活质量（HRQoL）。
招募了66名参与者。与咪达唑仑组相比，右美托咪定组在24小时、48小时及整个研究期间（0 - 14天）处于轻度镇静范围内的SBS评分数量更多（24小时：76/170[45%]对60/178[34%]，调整后比值比[aOR]4.14[95%置信区间0.48, 35.92]；48小时：154/298[52%]对122/314[39%]，aOR 6.95[95%置信区间0.77, 63.13]；0 - 14天：597/831[72%]对527/939[56%]，aOR 3.93[95%置信区间0.62, 25.03]）。确定了可行性，14天内无退出或失访情况，方案偏差最小化。两组在临床、安全、神经发育或HRQoL结局方面无差异。
与咪达唑仑相比，使用右美托咪定与更多时间处于轻度镇静状态相关。同时也确定了在接受心脏直视手术的儿童中对咪达唑仑和右美托咪定进行双盲随机对照试验的可行性。这些发现为在更大规模试验中进行进一步研究提供了依据。
ACTRN12615001304527。
