新型内镜鼻面罩在保留呼吸的静脉麻醉中有效性和安全性——单盲、随机、阳性器械平行对照临床研究

Efficacy and safety of a novel endoscopic nasal mask in respiratory-sparing intravenous anesthesia: a single blind, randomized, positive-device parallel-controlled clinical trial

摘要:

目的 本研究探讨专利产品——新型内镜鼻面罩（其带有可脱卸的口咽通气道）在保留自主呼吸的短小静脉麻醉中的安全性、有效性及可操作性。方法 选择94例拟行宫腔镜检查、乳房肿块切除术的患者，随机分为两组: 对照组采用喉罩辅助通气，试验组采用新型内镜鼻面罩辅助通气，两组均使用右美托咪定联合舒芬太尼、丙泊酚完成保留呼吸的静脉麻醉。主要观察指标: 患者在麻醉诱导后低氧血症[血氧饱和度(oxygen saturation, SpO2)<90%]发生率；高碳酸血症[呼气末二氧化碳分压(end-tidal carbon dioxide, PetCO2)>45mmHg，1mmHg=0.133kPa]发生率；次要观察指标: 手术前后两次动脉血气分析中动脉血氧分压(the alveolar oxygen pressure, PaO2)和动脉血二氧化碳分压(the alveolar carbon dioxide pressure, PaCO2)变化情况。结果 两组患者均顺利完成手术麻醉，尽管试验组（19.1%，9/47）低氧血症发生率高于对照组（12.8%，6/47，P=0.389，但差异无统计学意义；试验组高碳酸血症（PetCO2>45mmHg）发生情况低于对照组（P=0.006）；通过对术前和术后血气进行分析发现，两组患者PaO2和PaCO2差异无统计学意义（P>0.05）。结论 两组方法均能安全有效地用于短小手术的麻醉。对于保留自主呼吸的短小日间手术，新型内镜鼻面罩作为面罩与喉罩之间的通气工具，可安全有效应用于该类手术，完成有效通气。

Abstract:

Objective To investigate the safety and efficacy of a patented novel endoscopic nasal mask with a removable oropharyngeal airway in short intravenous anesthesia with spontaneous breathing. Methods A total of 94 patients undergoing hysteroscopy or lumpectomy under intravenous anesthesia with spontaneous breathing were randomly divided into two groups with 47 cases in each group. The control group was treated with LMA laryngeal mask-assisted ventilation, and the study group was treated with the novel endoscopic nasal mask-assisted ventilation. The primary outcome measures were the occurrence of hypoxemia(SpO2<90%) after anesthesia induction and the occurrence of hypercapnia(PetCO2>45mmHg) due to respiratory depression. The secondary outcome measures were changes of PaO2 and PaCO2 in two arterial blood gas analyses. Results Anesthesia was successfully completed in patients of both groups. The incidence of hypoxemia in the study and control groups was 19.1%(9/47) and 12.8%(6/47), respectively(P=0.389). The incidence of hypercapnia(PetCO2>45mmHg) in the study group was lower than that in the control group(P=0.006). There was no significant difference in PaO2 and PaCO2 between the two groups(P>0.05). Conclusion The novel endoscopic nasal mask can be safely used to achieve effective ventilation in short surgery under intravenous anesthesia with spontaneous breathing.