右美托咪定含服用于患儿面罩吸入麻醉诱导前镇静的半数有效剂量

Median effective dose of buccal dexmedetomidine sedation for acceptance of face mask during inhalational induction in children

目的测定右美托咪定含服用于患儿面罩吸入麻醉诱导前镇静的半数有效剂量(ED_(50))与95%有效剂量(ED_(95))。方法选择ASAⅠ级接受面罩吸入麻醉诱导的患儿,年龄2~6岁,体重指数18~25 kg·m^(-2),预计40例。麻醉前1 h口内含服右美托咪定,根据预计试验起始剂量设为3μg·kg^(-1),剂量按改良序贯法进行调整,根据上一例患儿吸入麻醉诱导时面罩接受时的镇静效果,下一例患儿增加或减少0.25μg·kg^(-1)。重复此过程至出现第七个交换点即研究结束,镇静效果以面罩接受满意程度四分法进行评估。采用Probit概率单位回归分析法计算右美托咪定的ED50和ED95及相应的95%可信区间(95%CI)。结果共入选患儿31例,年龄(4.57±1.46)岁,体重指数(22.13±2.66)kg·m^(-2)。患儿接受面罩的镇静效果满意15例,不满意16例,右美托咪定含服镇静的ED50为3.04μg·kg^(-1)(95%CI:2.77~3.67μg·kg^(-1)),ED95为3.67μg·kg^(-1)(95%CI:3.35~6.16μg·kg^(-1))。未见严重不良反应发生。结论麻醉前1 h右美托咪定含服用于患儿面罩吸入麻醉诱导前镇静的ED50和ED95分别为3.04μg·kg^(-1)和3.67μg·kg^(-1)。

AIM To determine the median buccal dexmedetomidine sedation for acceptance effective dose （ED50） and 95% effective dose （ED95） of of face mask during inhalational anesthesia induction in children. METHODS The children with ASA physical status I , aged 2-6 years old, body weight index 18- 25 kg· m-2, scheduled for acceptance of face mask during inhalational anesthesia induction were allocated, and the case number expectation was 40. Every child received dexmedetomidine buccally 1 h before inhalational induction. The initial dose of buccal dexmedetomidine was set at 3 μg·kg^-1 depending on preliminary experiments, and the dose of buccal dexmedetomidine was adjusted using the modified Dixon＇s up- and- down method depending on the sedation effect of the previous children, with an increment or decrement of 0.25 μg·kg^-1. The study ended until the seventh cross-over point was obtained. The child＇s acceptance of face mask was evaluated using a different 4-point scale. Probit analysis was used for calculating ED50, ED95 and 95% confidence interval （CI） of buccal dexmedetomidine sedation. RESULTS Total 31 children were enrolled practically. The age was （4.57 ± 1.46） years and the body weight index was （22.13±2.66） kg·m-2. The child＇s acceptance of face mask was satisfactory in 15 cases and unsatisfactory in 16 cases. The ED50 of buccal dexmedetomidine sedation was 3.04μg·kg^-1 （95%CI ： 2.77-3.67 μg·kg^-1） , and the ED95 of buccal dexmedetomidine sedation was 3.67 μg·kg^-1 （95%CI： 3.35-6.16μg·kg^-1）. No serious adverse reactions occurred. CONCLUSION The EDs0 and ED95 of buccal dexmedetomidine sedation is 3.04 μg·kg^-1 and 3.67 μg·kg^-1 respectively for acceptance of face mask 1 h before inhalational anesthesia induction in children.