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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
530
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.
Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.
Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.
San Donato Hospital
Arezzo, Italy
Desaturation Index
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);
Time frame: Trough study completion, an average of 2 years
Blood Pressure
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).
Time frame: Trough study completion, an average of 2 years
Heart Rate
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;
Time frame: Trough study completion, an average of 2 years
Respiratory Effects
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 frame: Trough study completion, an average of 2 years
Time in the recovery area
Time spent in the recovery area (in minutes)
Time frame: Trough study completion, an average of 2 years
A postanesthetic recovery score (Aldrete)
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.
Time frame: Trough study completion, an average of 2 years
Rapid On Site Evaluation results
i.e.: procedure with suitable sample (Yes or Not)
Time frame: Trough study completion, an average of 2 years
Total desaturation time
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.
Time frame: Trough study completion, an average of 2 years
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