PDF(Pubmed)
Abstract：
BACKGROUND: Motor-evoked potentials (MEP) are widely used to mitigate the risk of nerve injury resulting from surgical manipulation. Infants are more susceptible to anaesthetics that suppress MEP because of the immaturity of their nervous structures. Current evidence of the impact of the interaction between a small dose of sevoflurane and propofol-based total intravenous anaesthesia (TIVA) on MEP in infants is controversial. This current study aims to evaluate the impact of the coadministration of low-dose sevoflurane with propofol-based TIVA on MEP in infants.
METHODS: A randomised controlled study will be conducted at a single tertiary care children\'s hospital in Japan between July 2024 and June 2029. Children between 35 and 87 weeks of postconceptual age undergoing spinal surgery requiring MEP under general anaesthesia will be enrolled in this study. The participants will be randomly allocated into two groups: propofol+remifentanil with (intervention group) or without (control group) low-dose sevoflurane (0.10-0.15 age-adjusted minimum alveolar concentration). MEP top-to-bottom amplitudes will be measured at two chronological points: T1 (first transcranial MEP (TcMEP) recording), T2 (second TcMEP recording) in the same patient. The primary and secondary endpoints will be a reduction in MEP amplitudes (T1-T2) in the right upper and lower extremities between the control and intervention groups, respectively. The sample size was calculated to be a total of 40 based on the preliminary data of 10 infants, which showed a 35% reduction in mean values of MEP amplitudes in the right adductor muscle (SD=31) with a 10% assumed dropout rate.
BACKGROUND: The study protocol was approved by the Institutional Review Board of the Aichi Children\'s Health and Medical Center (2022058). The results will be reported in a peer-reviewed journal at the relevant academic conference.
BACKGROUND: jRCT1041230094.
METHODS: A randomised controlled study will be conducted at a single tertiary care children\'s hospital in Japan between July 2024 and June 2029. Children between 35 and 87 weeks of postconceptual age undergoing spinal surgery requiring MEP under general anaesthesia will be enrolled in this study. The participants will be randomly allocated into two groups: propofol+remifentanil with (intervention group) or without (control group) low-dose sevoflurane (0.10-0.15 age-adjusted minimum alveolar concentration). MEP top-to-bottom amplitudes will be measured at two chronological points: T1 (first transcranial MEP (TcMEP) recording), T2 (second TcMEP recording) in the same patient. The primary and secondary endpoints will be a reduction in MEP amplitudes (T1-T2) in the right upper and lower extremities between the control and intervention groups, respectively. The sample size was calculated to be a total of 40 based on the preliminary data of 10 infants, which showed a 35% reduction in mean values of MEP amplitudes in the right adductor muscle (SD=31) with a 10% assumed dropout rate.
BACKGROUND: The study protocol was approved by the Institutional Review Board of the Aichi Children\'s Health and Medical Center (2022058). The results will be reported in a peer-reviewed journal at the relevant academic conference.
BACKGROUND: jRCT1041230094.
摘要：
背景：运动诱发电位（MEP）被广泛用于减轻手术操作引起的神经损伤的风险。由于神经结构的不成熟，婴儿更容易受到抑制MEP的麻醉剂的影响。目前关于小剂量七氟醚和基于丙泊酚的全静脉麻醉（TIVA）之间相互作用对婴儿MEP的影响的证据存在争议。本研究旨在评估低剂量七氟烷与基于异丙酚的TIVA联合给药对婴儿MEP的影响。
方法：一项随机对照研究将于2024年7月至2029年6月在日本的一家三级儿童医院进行。这项研究将招募35至87周后概念年龄的儿童，这些儿童需要在全身麻醉下进行MEP的脊柱手术。参与者将被随机分为两组：丙泊酚+瑞芬太尼（干预组）或不使用（对照组）低剂量七氟醚（0.10-0.15年龄调整的最低肺泡浓度）。将在两个时间点测量MEP从上到下的振幅：T1（第一个经颅MEP（TcMEP）记录），同一患者的T2(第二次TcMEP记录)。主要和次要终点是对照组和干预组之间右上肢和下肢MEP振幅（T1-T2）的降低，分别。根据10名婴儿的初步数据,计算出的样本量共40个,显示右收肌中MEP幅度的平均值降低了35％（SD=31），假定脱落率为10％。
背景：研究方案已获得爱知儿童健康与医疗中心机构审查委员会的批准（2022058）。结果将在相关学术会议的同行评审期刊上报告。
背景：jRCT1041230094。
方法：一项随机对照研究将于2024年7月至2029年6月在日本的一家三级儿童医院进行。这项研究将招募35至87周后概念年龄的儿童，这些儿童需要在全身麻醉下进行MEP的脊柱手术。参与者将被随机分为两组：丙泊酚+瑞芬太尼（干预组）或不使用（对照组）低剂量七氟醚（0.10-0.15年龄调整的最低肺泡浓度）。将在两个时间点测量MEP从上到下的振幅：T1（第一个经颅MEP（TcMEP）记录），同一患者的T2(第二次TcMEP记录)。主要和次要终点是对照组和干预组之间右上肢和下肢MEP振幅（T1-T2）的降低，分别。根据10名婴儿的初步数据,计算出的样本量共40个,显示右收肌中MEP幅度的平均值降低了35％（SD=31），假定脱落率为10％。
背景：研究方案已获得爱知儿童健康与医疗中心机构审查委员会的批准（2022058）。结果将在相关学术会议的同行评审期刊上报告。
背景：jRCT1041230094。
