Sedation During Bronchoscopy
Conditions
Keywords
Balanced Analgosedation, Pulmonologist, Propofol, MIdazolam, Petidhine
Brief summary
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?
Detailed description
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. Propofol, compared to midazolam, is characterized by an even faster onset of action, but more importantly by higher clearance and redistribution, allowing for rapid recovery of consciousness even after prolonged infusions. Nevertheless, this drug is also associated with adverse effects, particularly on cardiac inotropic and chronotropic function as well as mean arterial pressure, thus requiring caution in its administration. The use of propofol-as per the technical data sheet approved by the Italian Medicines Agency (AIFA)-is reserved for doctors specialized in anesthesia or those experienced in the care of intensive care patients. Pulmonologists, with their specific training in respiratory function management, possess crucial skills in administering deep sedation, such as that induced by propofol, as patient safety largely depends on proper airway management during the procedure. The Complex Operative Unit of Pneumology and RICU (Respiratory Intensive Care Unit) at San Donato Hospital in Arezzo has extensive experience in the field of procedural analgesia. This study is driven by the need to generate scientific evidence supporting effective and safe alternatives for analgosedation managed by pulmonologists during bronchoscopic procedures. The aim is to consolidate and expand upon preliminary studies in the literature, with the goal of ensuring optimal sedation even in the absence of anesthesia assistance.
Interventions
DRUGPropofol 1%
Propofol 1% is infused intravenously, initially at a bolus dose of 0.5 mg/kg followed by a maintenance dose in a continuous infusion of 0.5-1.0 mg/kg/hour.
DRUGMidazolam
Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.
DRUGPethidine
Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.
Sponsors
Azienda USL Toscana Sud Est
Ospedale San Donato, Arezzo
Fondazione Andrea Cesalpino Arezzo ONLUS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Eligible patients may undergo flexible bronchoscopy based solely on clinical indications, with procedures classified as either interventional (e.g., laser therapy, ndotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS) or non-bioptic procedures, such as bronchial lavage, bronchoalveolar lavage, or endobronchial lavage. To ensure a balanced distribution of characteristics that could influence study outcomes, stratified block randomisation will be used. Patients will be stratified according to the type of bronchoscopic procedure (interventional vs simple), as the complexity and invasiveness of the procedure may influence the required depth of sedation. Within each group, block randomisation with a 1:1 ratio will be applied to ensure a consistent balance of patients recruited between treatment groups (Propofol+Pethidine or Midazolam+Pethidine).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of either sex aged \> 18 years; 2. Patients able to understand and sign an informed consent to participation and data collection. 3. 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). 4. Patients who must undergo bronchoscopy, scheduled as an elective, for therapeutic reasons (bronchial toilet, mechanical or laser-assisted airway recanalisation)
Exclusion criteria
1. Patients unable to understand and sign an informed consent to participation and data collection. 2. Interventional procedures performed as a matter of urgency or without prior adequate time to clarify the methodology and objectives of the study. 3. Hypersensitivity to investigational drugs (propofol, pethidine, midazolam, local anaesthetics such as lidocaine). 4. 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. 5. 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. 6. Inability to spontaneously protect the airways and manage bronchial secretions. 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desaturation Index | 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); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Trough study completion, an average of 2 years | This involves comparing the rates of peri- and post-procedural complications between the two treatment arms. \- Bradycardia defined as a rate \<50 bpm requiring fluid therapy, vasoactive/inotropic therapy; |
| Respiratory Effects | Trough study completion, an average of 2 years | This involves comparing the rates of peri- and post-procedural complications between the two treatment arms. \- Respiratory effects: bronchospasm or wheezing requiring systemic corticosteroids, aerosolized or systemic bronchodilator therapy (e.g., beta agonists, magnesium sulphate). |
| Time in the recovery area | Trough study completion, an average of 2 years | Time spent in the recovery area (in minutes) |
| Blood Pressure | Trough study completion, an average of 2 years | This involves comparing the rates of peri- and post-procedural complications between the two treatment arms. * Hypotension defined by a systolic blood pressure \<90 mmHg or a diastolic blood pressure \<50 mmHg. * Hypotension requiring fluid therapy, vasoactive/inotropic therapy (yes or not). |
| Rapid On Site Evaluation results | Trough study completion, an average of 2 years | i.e.: procedure with suitable sample (Yes or Not) |
| Total desaturation time | Trough study completion, an average of 2 years | Total desaturation time is defined as the cumulative time a patient's oxygen saturation (SpO2) falls below a predefined threshold (SpO2\<90%) during the procedure. |
| A postanesthetic recovery score (Aldrete) | Trough study completion, an average of 2 years | Patient recovery assessed by Aldrete score. It evaluates a patient's recovery after anesthesia based on five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored from 0 to 2, resulting in a total score ranging from 0 (minimum) to 10 (maximum). Investigators will consider patient recovery achieved with an Aldrete score ≥9. |
Countries
Italy
Contacts
Primary ContactRaffaele Scala, MD
Outcome results
None listed