Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine

Phase 4

Not yet recruiting

• Conditions: Sedation During Bronchoscopy
• Interventions: Drug: Propofol 1%; Drug: Midazolam; Drug: Pethidine

• Registration Number: NCT06736938
• Lead Sponsor: Fondazione Andrea Cesalpino Arezzo ONLUS

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.

Study Timeline

• Study First Submitted: 2024-11-09
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-04-01
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 530

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-bioptic Bronchoscopy	Propofol 1%	such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.
Interventional Bronchoscopy	Propofol 1%	eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
Interventional Bronchoscopy	Midazolam	eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
Interventional Bronchoscopy	Pethidine	eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
Non-bioptic Bronchoscopy	Midazolam	such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.
Non-bioptic Bronchoscopy	Pethidine	such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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.
Time in the recovery area	Trough study completion, an average of 2 years	Time spent in the recovery area (in minutes)
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.

Trial Locations

Locations (1)

San Donato Hospital; 🇮🇹 Arezzo, Italy