固定剂量ENG N=50 data.sav

Sedation is recommended by most guidelines to be offered to all patients undergoing diagnostic flexible bronchoscopy(DFB)without contraindications, and the most commonly reported regimen is midazolam in combination with a short-acting opioid (fentanyl or alfentanil) to provide both sedative and antitussive effects. However, the optimal dose or ideal regimen of the combination therapy with midazolam and opioids has not yet been found. So this randomized, double-blinded clinical trial was designed and registered (ChiCTR2100049052) to assess the safety and efficacy of midazolam combined with different doses of alfentanil in DFB sedation.Our study showed that relative high doses of alfentanil (10-25mg/kg) combined with a fixed low dose of midazolam can markedly reduce hemodynamic fluctuations, cough reactions, patients’ discomforts, and improve their satisfaction in a dose-dependent manner during DFB, with no significant increase in the desaturation risks.多数临床指南推荐，无禁忌证的诊断性可弯曲支气管镜（diagnostic flexible bronchoscopy, DFB）受检患者均应接受镇静干预。当前临床最常用的镇静方案为咪达唑仑联合短效阿片类药物（芬太尼或阿芬太尼），以同时实现镇静与镇咳效应。然而，咪达唑仑与阿片类药物联合治疗的最优剂量及理想方案目前仍未明确。为此，本研究设计并注册了一项随机双盲临床试验（试验编号：ChiCTR2100049052），旨在评估咪达唑仑联合不同剂量阿芬太尼用于DFB镇静的安全性与有效性。本研究结果显示，在DFB检查过程中，固定低剂量咪达唑仑联合相对高剂量阿芬太尼（10~25mg/kg）可显著减轻血流动力学波动、咳嗽反应及患者不适感，并以剂量依赖性方式提升患者满意度，且未显著增加低氧血症发生风险。