METHODS: A single-center, parallel-group, two-arm, superiority trial with a 1:1 allocation ratio will be performed to compare the incidence of PAED following standard sevoflurane anesthesia (maintained at 1.0MAC) and EEG-guided anesthesia (minimum concentration to sustain surgical anesthesia as determined by monitoring of EEG signatures). Participants between 1 and 6 years of age undergoing surgical procedures involving minimal postoperative pain will be randomly assigned to receive standard (n = 90) or EEG-guided (n = 90) anesthesia. PAED score will be assessed by a blinded observer in the PACU on arrival and after 5, 10, 15, and 30 min.
CONCLUSIONS: Anesthesia management with proactive use of brain function monitoring is expected to reduce exposure to sevoflurane without compromising surgical anesthesia. We expect this reduced exposure should help prevent PAED. Routinely administering what may be considered standard levels of anesthetic such as 1.0 MAC sevoflurane may be excessive and potentially associated with unfavorable sequelae such as PAED.
BACKGROUND: Japan Registry of Clinical Trials (jRCT) jRCTs032210248. Prospectively registered on 17 August 2021.
方法:单中心,平行组,双臂,将进行1:1分配比的优势试验,以比较标准七氟醚麻醉(维持在1.0MAC)和脑电图引导麻醉(通过监测脑电图特征确定的维持手术麻醉的最低浓度)后PAED的发生率.年龄在1至6岁之间的参与者将被随机分配接受标准(n=90)或脑电图引导(n=90)麻醉。PAED评分将在到达时以及5、10、15和30分钟后由PACU中的盲观察者评估。
结论:积极使用脑功能监测的麻醉管理有望在不影响手术麻醉的情况下减少七氟醚的暴露。我们预计这种减少的暴露应该有助于预防PAED。常规给药可能被认为是标准水平的麻醉剂如1.0MAC七氟醚可能是过量的并且可能与不利的后遗症如PAED有关。
背景:日本临床试验注册(jRCT)jRCTs032210248。预计于2021年8月17日注册。