Zheng Zong, Yang Shanpu, Liu Hongyan, Sheng Zhimin
Department of Neonatology, People's Hospital of Yuhuan City, Taizhou, China.
Department of Anesthesiology, Wenling Maternity and Child Health Care Hospital, Taizhou, China.
Front Pediatr. 2025 Aug 12;13:1629088. doi: 10.3389/fped.2025.1629088. eCollection 2025.
Neonatal sedation depth monitoring is critical yet depends on the subjective Ramsay scale when used and lacks objective biomarkers. Although auditory evoked potential (AEP) wave VI disappearance is linked to reduced consciousness, its use for neonatal sedation monitoring remains underexplored. We aimed to determine whether wave VI could function as an objective indicator of sedation levels in neonates.
This prospective, double-blind, randomized trial enrolled 100 neonates requiring hearing screening. Participants were randomly assigned in a 4:1 ratio to either the treatment group ( = 80; 50 mg/kg oral chloral hydrate) or the control group ( = 20; 0.9% saline placebo). The treatment group was further divided into three subgroups according to Ramsay sedation scores, namely, level 4 ( = 22), level 5 ( = 23), and level 6 ( = 35), while the control group was divided into level 3 ( = 5), level 4 ( = 12), and level 5 ( = 3). All neonates received a standardized AEP test performed by an experienced audiologist. Sedation depth was evaluated using the Ramsay scale, and the latency and disappearance rate of wave VI were recorded and correlated with sedation levels. The receiver operating characteristic (ROC) curve was used to evaluate the predictive ability of wave VI latency in deep sedation, analyzing its sensitivity, specificity, and predictive values.
In the treatment group, wave VI disappearance rates increased in a sedation-dependent manner across the Ramsay Sedation Scale: 0% at level 4, 26% at level 5, and 68.6% at level 6 ( < 0.05). No wave VI disappearance was observed in the control group. ROC analysis demonstrated that wave VI latency predicted deep sedation (Ramsay ≥ 5) with an area under the curve of 0.861 (95% confidence interval: 0.746-0.975). The optimal latency cutoff was 8.465 ms (72.7% sensitivity, 86.2% specificity).
AEP wave VI latency and disappearance are objective, sensitive, and specific indicators of sedation depth in neonates. With further validation, wave VI has the potential to become a reliable neurophysiological tool for precise sedation monitoring in neonates.
https://www.chictr.org.cn/index.html, identifier ChiCTR2300068407.
新生儿镇静深度监测至关重要，但目前使用时依赖主观的 Ramsay 评分量表，且缺乏客观生物标志物。尽管听觉诱发电位（AEP）的 VI 波消失与意识水平降低有关，但其在新生儿镇静监测中的应用仍未得到充分探索。我们旨在确定 VI 波是否可作为新生儿镇静水平的客观指标。
这项前瞻性、双盲、随机试验纳入了 100 名需要听力筛查的新生儿。参与者按 4:1 的比例随机分为治疗组（n = 80；口服 50 mg/kg 水合氯醛）或对照组（n = 20；0.9% 生理盐水安慰剂）。治疗组根据 Ramsay 镇静评分进一步分为三个亚组，即 4 级（n = 22）、5 级（n = 23）和 6 级（n = 35），而对照组分为 3 级（n = 5）、4 级（n = 12）和 5 级（n = 3）。所有新生儿均由经验丰富的听力学家进行标准化的 AEP 测试。使用 Ramsay 量表评估镇静深度，记录 VI 波的潜伏期和消失率，并与镇静水平进行相关性分析。采用受试者操作特征（ROC）曲线评估 VI 波潜伏期对深度镇静的预测能力，分析其敏感性、特异性和预测值。
在治疗组中，Ramsay 镇静量表各等级的 VI 波消失率呈镇静依赖性增加：4级为0%，5级为26%，6级为68.6%（P < 0.05）。对照组未观察到 VI 波消失。ROC 分析表明，VI 波潜伏期对深度镇静（Ramsay≥5）具有预测作用，曲线下面积为 0.861（95% 置信区间：0.746 - 0.975）。最佳潜伏期截断值为 8.465 ms（敏感性为 72.7%，特异性为 86.2%）。
AEP 的 VI 波潜伏期和消失是新生儿镇静深度的客观、敏感和特异指标。经过进一步验证，VI 波有可能成为用于新生儿精确镇静监测的可靠神经生理学工具。
https://www.chictr.org.cn/index.html，标识符 ChiCTR2300068407。
