右美托咪定注射剂复合罗哌卡因注射剂用于儿外科手术的临床研究

Clinical trial of dexmedetomidine injection combined with ropivacaine injection in the treatment of pediatric surgery

目的观察右美托咪定注射剂复合罗哌卡因注射剂用于儿外科手术的临床疗效及安全性。方法将120例下腹及下肢择期手术的患儿随机分为A,B,C和D组,每组30例。A组予以等容量0.9%Na Cl滴鼻+1 mL·kg^(-1)0.25%罗哌卡因骶管阻滞;B组予以等容量0.9%Na Cl滴鼻,1 mL·kg^(-1)0.25%罗哌卡因+1μg·kg^(-1)右美托咪定骶管阻滞;C组予以1μg·kg^(-1)右美托咪定滴鼻,1 mL·kg^(-1)0.25%罗哌卡因骶管阻滞;D组予以1μg·kg^(-1)右美托咪定滴鼻,1 mL·kg^(-1)0.25%罗哌卡因+1μg·kg^(-1)右美托咪定骶管阻滞。比较4组患儿的阻滞起效时间、苏醒时间、拔喉罩时间及苏醒期躁动评分(PAED),以及药物不良反应的发生情况。结果 A,B,C和D组的阻滞起效时间分别为(20.28±5.69),(17.93±4.95),(15.21±3.65)和(12.41±2.63)min,苏醒时间分别为(22.03±5.47),(18.31±7.39),(17.10±4.50)和(11.97±3.39)min,拔喉罩时间分别为(19.07±4.59),(15.86±2.50),(14.59±2.44)和(9.41±2.91)min,PAED分别为(13.55±2.71),(10.97±3.70),(10.62±2.08)和(5.62±2.47)分,D组的上述指标与A,B,C组比较,差异均有统计学意义(均P<0.05)。4组患儿的药物不良反应均以恶心呕吐、低氧血压和尿潴留为主,A,B,C和D组的总药物不良反应发生率分别为63.33%,53.33%,36.67%和16.67%,D组的总药物不良反应发生率与A,B,C组比较,差异均有统计学意义(均P<0.05)。结论右美托咪定注射剂复合罗哌卡因注射剂用于儿外科手术的临床疗效显著,其能显著减轻患儿苏醒期躁动,且安全性较好。

Objective To observe the clinical efficacy and safety of dexmedetomidine injection combined with ropivacaine injection in the treatment of pediatric surgery. Methods One hundred and twenty chil- dren with lower abdominal or lower limb elective surgery were randomly divided into groups A, B, C and D with 30 cases per group. Group A was given an equal volume of 0. 9% NaC1, intranasal administration 1 mL · kg-1 0. 25% ropivacaine for sacral block. Group B was given an equal volume of 0.9% NaCI, intranasal administration 1 mL · kg-I 0. 25% ropivacaine and 1 μg·kg-1dexmedetomidine for sacral block. Group C were given 1μg·kg-1dexmedetomidine, intranasal administra- tion 1 mL kg-1 0. 25% ropivacaine for sacral block. Group D wasgiven 1 μg·kg-1 dexmedetomidine, intranasal administration 1 mL · kg- 10. 25 % ropivacaine and 1 μg·kg-1 dexme- detomidine for sacral block. The block onset time, wake - up time, the time of laryngeal mask, pediatric anesthesia emergence delirium （PAED） and adverse drug reactions were compared between four groups. Results The main inde- xes in groups A, B, C and D were compared; block onset time were （20.28 ±5.69）, （17.93 ±4.95）, （15.21 ±3.65） and （ 12. 41 ± 2. 63） min, wake - up time were （22.03 ± 5.47 ）, （ 18.31 ± 7.39 ）, （ 17. 10 ± 4. 50） and （ 11.97 ± 3.39 ） rain, time of laryngeal mask were （ 19. 07 ± 4. 59）, （ 15.86 ± 2.50）, （ 14.59 ± 2. 44） and （9.41 ± 2. 91 ） min, PAED were （ 13.55 ± 2.71 ）, （ 10. 9i± 3.70）, （ 10± 62 ± 2.08） and （5.± 62 ±2. 47） points. The differences of all the items between groups were statistically significant （ all P 〈 0.05 ）. The adverse drug reactions in the four groups were nausea, vomiting, hypoxic blood pressure and urinary retention. The incidences of adverse drug reactions in groups A, B, C and D were 63.33%, 53.33%, 36.67% and 16. 67%. Of them, there were statistically significant differences between group D and groups A, B, C （ all P 〉 O. 05 ）. Conclusion Dexmedetomidine injection combined with ropiva- caine injection has a definitive clinical efficacy in the treatment of pediatric surgery, which can significantly reduce the pediatric anesthesia emergence delirium, without increasing the incidence of adverse drug reactions.