出现谵妄是儿童全身麻醉后的一种行为障碍,可能会困扰患者和主要照顾者。比如父母和医务人员,照顾病人.已经研究了各种医疗和情绪干预措施来减少出现谵妄;然而,没有一个是完全有效的。该试验旨在评估母亲的声音记录是否可以减少这种不良麻醉后事件并促进全身麻醉的唤醒。
这是一个潜在的,双盲,单中心,平行臂,优越性,在接受需要全身麻醉的择期手术的2-8岁参与者中进行随机对照试验。参与者将被随机分配到两组中的一组:那些通过听母亲录制的声音而被刺激醒来的人(母亲组,n=33)或陌生人的声音(陌生人组,n=33)在麻醉出现期间。主要结果是麻醉后监护病房(PACU)的初始出现谵妄评分。次要结果是血流动力学参数,包括心率和平均血压,麻醉停止与BIS水平60、70和80之间的持续时间,睁眼或有目的的运动时间,拔管时间,镇痛药的总消耗量,PACU停留时间,PACU住院期间出现谵妄和疼痛评分。
这是第一个研究母亲在苏醒期间录制的声音对全身麻醉后小儿苏醒情况影响的随机对照试验。它可以提供预防性治疗选择,以减少出现谵妄并增强全身麻醉的唤醒。
ClicnicalTrials.gov,ID:NCT02955680。2016年11月2日注册
Emergence delirium is a behavioral disturbance after general anesthesia in children and may distress both the patients and the primary caregivers, such as parents and medical staff, looking after the patients. Various medical and emotional interventions have been investigated to reduce emergence delirium; however, none are completely effective. This trial intends to assess whether the mother\'s recorded voice can reduce this adverse post-anesthesia event and facilitate arousal from general anesthesia.
This is a prospective, double-blind, single-center, parallel-arm, superiority, randomized controlled trial to be conducted in participants aged 2-8 years who are undergoing elective surgery requiring general anesthesia. Participants will be randomly assigned to one of two groups: those who are stimulated to wake up by listening to their mother\'s recorded voice (maternal group, n = 33) or a stranger\'s voice (stranger group, n = 33) during anesthetic emergence. The primary outcome is the initial emergence delirium score in the post-anesthesia care unit (PACU). The secondary outcomes are hemodynamic parameters, including heart rate and mean blood pressure, the duration of time between the cessation of anesthetics and a BIS level of 60, 70 and 80, eye-opening or purposeful movement time, extubation time, total consumption of analgesics, PACU stay time, emergence delirium and pain scores during the PACU stay.
This is the first randomized controlled trial to investigate the effect of a mother\'s recorded voice during emergence on the pediatric emergence profile after general anesthesia. It may provide prophylactic treatment options to decrease emergence delirium and enhance arousal from general anesthesia.
ClicnicalTrials.gov, ID: NCT02955680 . Registered on 2 November 2016.