Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Desaturation Index
研究概览
简要总结
The goal of this clinical trial is to compare the safety and efficacy of two pharmacological sedation regimens during bronchoscopy procedures in adult patients who require elective bronchoscopy.
The main questions it aims to answer are:
- Is propofol/pethidine analgesia administered by a pulmonologist as effective and safe as midazolam/pethidine in achieving adequate sedation during bronchoscopy, particularly in terms of desaturation rate?
- Does the choice of sedative (midazolam vs. propofol) influence the occurrence of adverse events or need for escalated care?
详细描述
Bronchoscopic procedures are essential in the diagnosis and management of various respiratory diseases, but they can cause significant discomfort for patients.
Analgosedation plays a crucial role in improving patient comfort while ensuring optimal conditions for the safe performance of the procedure. However, sedation management protocols can vary greatly depending on the hospital center and the availability of an anesthetist.
Over the years, with the increasing number of bronchoscopic procedures, the growing complexity of patients-particularly those with pulmonary diseases presenting comorbidities and significant gas exchange alterations-and the limited availability of anesthetists in national hospital facilities, there has been a growing reliance on independently managed procedural sedation.
This independent management-without the need for an anesthesia specialist-has been facilitated by the use of relatively easy-to-manage drugs like midazolam, a benzodiazepine (BDZ) with a pharmacokinetic profile that makes it preferable to other similar compounds due to its rapid onset of action and the availability of an antagonist capable of reversing its effects.
However, it is important to acknowledge that the use of midazolam carries significant risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex aged > 18 years;
- •Patients able to understand and sign an informed consent to participation and data collection.
- •Patients who have to undergo bronchoscopy, with or without echendoscopy, scheduled in the election, for diagnostic - staging reasons (BL or BAL with microbiological research, endobronchial biopsies, transbronchial biopsies in EBUS/EUS, EBUS/EUS-TBNA ilo-mediastinal lymph node station).
- •Patients who must undergo bronchoscopy, scheduled as an elective, for therapeutic reasons (bronchial toilet, mechanical or laser-assisted airway recanalisation)
排除标准
- •Patients unable to understand and sign an informed consent to participation and data collection.
- •Interventional procedures performed as a matter of urgency or without prior adequate time to clarify the methodology and objectives of the study.
- •Hypersensitivity to investigational drugs (propofol, pethidine, midazolam, local anaesthetics such as lidocaine).
- •Pre-existing haemodynamic instability or clinical conditions that may predispose to such instability during the procedure. This includes patients with acute coronary syndrome within the last 4-6 weeks, those requiring treatment with inotropes or vasoactive drugs to maintain a PAS>90 mmHg, and patients with heart failure with reduced ejection fraction (FE <40%), as defined by ESC guidelines.
- •Compromised respiratory exchanges already present before the procedure, including those requiring non-invasive ventilation (NIV), high-flow oxygen therapy via nasal cannulae (HFNC), those hospitalised for severe acute respiratory failure and patients on continuous home oxygen therapy (h24). This exclusion is necessary to avoid potential bias that could influence the study results and compromise their interpretation.
- •Inability to spontaneously protect the airways and manage bronchial secretions.
研究组 & 干预措施
Interventional Bronchoscopy
eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
干预措施: Propofol 1% (Drug)
Interventional Bronchoscopy
eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
干预措施: Midazolam (Drug)
Interventional Bronchoscopy
eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
干预措施: Pethidine (Drug)
Non-bioptic Bronchoscopy
such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.
干预措施: Propofol 1% (Drug)
Non-bioptic Bronchoscopy
such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.
干预措施: Midazolam (Drug)
Non-bioptic Bronchoscopy
such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.
干预措施: Pethidine (Drug)
结局指标
主要结局
Desaturation Index
时间窗: Trough study completion, an average of 2 years
The primary endpoint of this study is to evaluate and compare the desaturation index (SpO2 \< 90% for at least 30 seconds) between the two drug regimens. The analysis will be conducted both across all procedures and stratified by type (interventional vs simple);
次要结局
- Blood Pressure(Trough study completion, an average of 2 years)
- Heart Rate(Trough study completion, an average of 2 years)
- Respiratory Effects(Trough study completion, an average of 2 years)
- A postanesthetic recovery score (Aldrete)(Trough study completion, an average of 2 years)
- Time in the recovery area(Trough study completion, an average of 2 years)
- Rapid On Site Evaluation results(Trough study completion, an average of 2 years)
- Total desaturation time(Trough study completion, an average of 2 years)
研究者
Raffaele Scala
Head of COU Pulmonology and RICU - San Donato Hospital
Fondazione Andrea Cesalpino Arezzo ONLUS