新生儿选择性气管插管前阿托品与芬太尼联合应用插管成功率和安全性的随机对照研究

目的 评估新生儿选择性气管插管前阿托品和芬太尼联合应用的插管成功率和安全性。方法 选取2009年11月至2010年4月于南京医科大学附属南京儿童医院NICU行选择性气管插管的新生儿为研究对象，随机分为试验组和对照组。试验组于气管插管前先缓慢静脉推注5%葡萄糖2 mL+阿托品0.02 mg·kg-1，后缓慢静脉推注5%葡萄糖2 mL+芬太尼2~4 μg·kg-1；对照组于气管插管前先后缓慢静脉推注5%葡萄糖2 mL和5%葡萄糖2 mL。对研究对象和插管医生实施盲法。记录一次插管成功率、插管时间、平均插管次数、Goldberg评分、不良反应(胸壁僵直皮囊加压困难、SpO2<80%、HR<100·min-1、严重的心动过缓需要胸外按压及鼻腔或口腔出血)发生率、经头颅B超评估颅内出血的发生率和撤机时间。结果 研究期间62例新生儿入组，其中试验组30例，对照组32例。两组基线资料具可比性。两组患儿经鼻插管受阻改经口插管均为2例，余均经鼻插管。试验组的芬太尼平均用量为2.4 μg·kg-1。试验组一次插管成功率显著高于对照组，63.3%（19/30例） vs 31.3%（10/32例），P=0.011。试验组平均插管时间显著低于对照组，（36±18）s vs （54±24）s，P=0.001。试验组平均插管次数显著低于对照组，（1.5±0.7）次 vs （2.0±0.8）次,P=0.005。试验组Goldberg评分显著低于对照组，（4.3±1.6）分 vs （6.8±1.8）分，P=0.000。两组不良反应发生率、撤机时间和颅内出血发生率差异均无统计学意义(均P>0.05)。结论 在新生儿选择性气管插管前联合应用阿托品与芬太尼，可提高一次插管成功率，缩短插管时间和插管次数，具有较好的安全性。

Randomized controlled trial on intubation success rate and safety of using atropine and fentanyl for selective intubation in neonates

【Abstract】Objective:To investigate the safety and efficiency of using Atorpine and Fentanyl as premedication for elective intubation in neonates. Method: Divide the neonates who receiving elective intubation(62cases) to two groups from 2009 november to 2010 april in NICU of NanJing Children’s Hospital, Group A(30cases)’s premedications are Atropine and Fentanyl , Group B(32cases)’s premedications are placebo. The same procedures are done according to the protocol in two groups. Recorded patients’ basical information, one attempt successful intubation, total attempts, time take to intubate, Goldberg scores and side effects. Result: 30 cases in group A, 32 in group B, There is no statistical significance in patients’ basical information(P>0.05). One attempt successful intubation is 63.3%(19cases) in group A，higher than 13.2%(10cases) in group B(P<0.05),which has statistical significance between groups. Average attempts of each patient is 1.47±0.68in group A lower than2.03±0.82 in group B(P<0.05), Goldberg score is 4.33±1.58 in group A lower than 6.81±1.79in group B(P<0.05). The time take to intubate is 35.77±18.42seconds in group A lower than 54.19±24.10seconds in group B(P<0.05). mouth or nose bleeding is 13.3%(4 cases) in group A lower than 21.9%(7 cases) in group B(P>0.05)，bradyrhythmia（heart rate<100bpm）is 16.7%(5cases) in group A lower than 27.3%(9cases) in group B(P>0.05), serious bradyrhythmia(heart rate<60bpm) is 3.33%(1 cases) in group A lower than 6.25%(2cases) in group B(P>0.05), desatuation (<80%) was 43.3%(13cases) in group A lower than54.5%(18cases) in group B, hard bagging is 6.7%s(2case) in group A and no one in group B, but there is no statistical significance between groups(P>0.05). Conclusion: Atropine and Fentanyl are safe as the premedication used in neonates, which can improve one attempt successful intubation avoiding bouche and nasal cavity tissue damage of repeating attempts. The use of premedication reduces the time taken to intubate. Atropine, fentanyl before elective intubation has led to a good intubation conditions with no adverse events in neonates.