College of Stomatology, Chongqing Medical University, Chongqing, China.
Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing, China.
BMC Pediatr. 2021 Apr 16;21(1):177. doi: 10.1186/s12887-021-02649-5.
Dental procedures under general anesthesia (DGA) was found to improve the oral health-related quality of children's life. However, some parents and pediatricians expressed concern about the neurotoxicity of general anesthesia. The purpose of this trial was to whether DGA in children has an adverse effect on neurocognition.
In this prospective, assessor-masked, controlled, equivalence trial, we recruited 340 children younger than 7 years who were undergoing caries treatment between Feb 1, 2019, and Aug 31, 2019, without factors affecting neurodevelopment. They received either sevoflurane-based general anesthesia or awake-local anesthesia. The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition was used to evaluate the neurocognitive function of children at 6 months after surgery, and the Full-Scale IQ (FSIQ) was selected as the primary outcome. The predefined clinical equivalence margin was 5 (1/3 SD of FSIQ score). If the 95% CI of the difference between the average FSIQ score of the two groups is within - 5 to + 5, then the two groups are equivalent.
The outcome data were obtained from 129 children in the general anesthesia group and 144 in the local anesthesia group. The median length of general anesthesia was 130 min (IQR 110-160). The mean FSIQ score in the general anesthesia group was 103·12 (SD 8.94), and the mean of the local anesthesia group was 103·58 (SD 8.40). There was equivalence in means of FSIQ score between the two groups (local minus general anesthesia 0.46, 95% CI - 2.35 to 1.61). There was no significant difference in FSIQ scores between different age groups and different anesthesia durations. Only the mother's education could affect the primary outcome.
In this trial, prolonged DGA with a sevoflurane-only anesthetic in preschool children, does not adversely affect neurocognitive function at 6 months after surgery compared with awake-local anesthesia.
Chinese Clinical Trial Registry, ChiCTR1800015216 . Registered Mar 15 2018.
全身麻醉下的牙科治疗(DGA)被发现可提高儿童的口腔健康相关生活质量。然而,一些家长和儿科医生对全身麻醉的神经毒性表示担忧。本试验旨在确定儿童的 DGA 是否对神经认知有不良影响。
在这项前瞻性、评估者设盲、对照、等效性试验中,我们招募了 340 名年龄在 7 岁以下、正在接受龋齿治疗的儿童,这些儿童在 2019 年 2 月 1 日至 2019 年 8 月 31 日期间没有影响神经发育的因素。他们接受七氟醚全身麻醉或清醒局部麻醉。术后 6 个月采用韦氏学龄前及小学儿童智力量表第四版评估儿童的神经认知功能,选用全量表智商(FSIQ)作为主要结局。预设的临床等效界值为 5(FSIQ 得分的 1/3 标准差)。如果两组平均 FSIQ 差值的 95%置信区间在-5 到+5 之间,则两组等效。
全身麻醉组和局部麻醉组各有 129 名和 144 名儿童获得了结局数据。全身麻醉的中位时间为 130 分钟(IQR 110-160)。全身麻醉组的 FSIQ 平均得分 103.12(SD 8.94),局部麻醉组的平均得分 103.58(SD 8.40)。两组 FSIQ 得分的平均值等效(局部麻醉减去全身麻醉 0.46,95%CI -2.35 至 1.61)。不同年龄组和不同麻醉持续时间之间的 FSIQ 评分无显著差异。只有母亲的教育程度可能会影响主要结局。
在本试验中,与清醒局部麻醉相比,全身麻醉(仅使用七氟醚)在学龄前儿童中持续时间较长,不会对术后 6 个月的神经认知功能产生不利影响。
中国临床试验注册中心,ChiCTR1800015216。注册于 2018 年 3 月 15 日。