Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine (ABroProMida)

December 15, 2024 updated by: Raffaele Scala, Fondazione Andrea Cesalpino Arezzo ONLUS

Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

530

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interventional Bronchoscopy
eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS
Drug: Propofol 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.
Drug: Midazolam
Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.
Drug: Pethidine
Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.
Active Comparator: Non-bioptic Bronchoscopy
such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.
Drug: Propofol 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.
Drug: Midazolam
Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.
Drug: Pethidine
Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation Index
Time Frame: 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);
Trough study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 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).
Trough study completion, an average of 2 years
Heart Rate
Time Frame: 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;
Trough study completion, an average of 2 years
Respiratory Effects
Time Frame: 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).
Trough study completion, an average of 2 years
Time in the recovery area
Time Frame: Trough study completion, an average of 2 years
Time spent in the recovery area (in minutes)
Trough study completion, an average of 2 years
A postanesthetic recovery score (Aldrete)
Time Frame: 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.
Trough study completion, an average of 2 years
Rapid On Site Evaluation results
Time Frame: Trough study completion, an average of 2 years
i.e.: procedure with suitable sample (Yes or Not)
Trough study completion, an average of 2 years
Total desaturation time
Time Frame: 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.
Trough study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Andrea Cesalpino Arezzo ONLUS

Collaborators

Azienda USL Toscana Sud Est
Ospedale San Donato, Arezzo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 9, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20245188206500
  • 2024-518820-65-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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