"Efficacy and safety of Balanced Analgosedation in Bronchoscopy with Propofol/Pethidine versus Midazolam/Pethidine: a single-centre randomised controlled trial (ABroProMida Study)"
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- The primary endpoint of our study is to evaluate and compare the desaturation index (SpO2 < 90% for at least 30 seconds) between the two drug regimens (Propofol+Petidine vs Midazolam+Petidine)..
研究概览
简要总结
The main objective of this study is to assess and compare the safety and efficacy of two pharmacological regimens (Propofol + Petidine vs Midazolam + Petidine), administered independently by the medical staff of Pulmonology and RICU at San Donato Hospital in Arezzo to facilitate procedural sedation in patients undergoing bronchoscopic procedures.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex aged > 18 years, capable of understanding and providing informed consent, scheduled for elective bronchoscopy, with or without echoendoscopy, for diagnostic/staging purposes or for therapeutic purposes.
排除标准
- •Patients unable to understand and sign informed consent; requiring urgent interventional procedures; with known hypersensitivity to the study drugs (propofol, pethidine, midazolam) or local anesthetics (such as lidocaine); with pre-existing haemodynamic instability or clinical conditions that could predispose them to instability during the procedure; with pre-existing compromised respiratory function prior to the procedure, including those on non-invasive ventilation (NIV), high-flow nasal cannula oxygen therapy (HFNC), those hospitalised for severe acute respiratory failure, and individuals on continuous home oxygen therapy (24 hours/day).
结局指标
主要结局
The primary endpoint of our study is to evaluate and compare the desaturation index (SpO2 < 90% for at least 30 seconds) between the two drug regimens (Propofol+Petidine vs Midazolam+Petidine)..
The primary endpoint of our study is to evaluate and compare the desaturation index (SpO2 < 90% for at least 30 seconds) between the two drug regimens (Propofol+Petidine vs Midazolam+Petidine)..
次要结局
- Adverse events (AEs); Procedural Tolerance using scores like the Aldrete score; Serious Adverse Events (SAE); Procedure Time; Final diagnostic yield.
研究者
Valentina Fabbrini
Scientific
Azienda Unita' Sanitaria Locale Toscana Sud Est