Clinical trial NCT06736938: Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine
Official title: Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sedation During Bronchoscopy
Keywords: Balanced Analgosedation
Pulmonologist
Propofol
MIdazolam
Petidhine
Lead sponsor: Fondazione Andrea Cesalpino Arezzo ONLUS
Sponsor class: OTHER
Collaborators: name: Azienda USL Toscana Sud Est
name: Ospedale San Donato, Arezzo
First posted: 2024-12-17
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Desaturation Index
timeFrame: Trough study completion, an average of 2 years
Secondary outcomes:
measure: Blood Pressure
timeFrame: Trough study completion, an average of 2 years
measure: Heart Rate
timeFrame: Trough study completion, an average of 2 years
measure: Respiratory Effects
timeFrame: Trough study completion, an average of 2 years
measure: Time in the recovery area
timeFrame: Trough study completion, an average of 2 years
measure: A postanesthetic recovery score (Aldrete)
timeFrame: Trough study completion, an average of 2 years
measure: Rapid On Site Evaluation results
timeFrame: Trough study completion, an average of 2 years
measure: Total desaturation time
timeFrame: Trough study completion, an average of 2 years
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: San Donato Hospital
Study officials:
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