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"Efficacy and safety of Balanced Analgosedation in Bronchoscopy with Propofol/Pethidine versus Midazolam/Pethidine: a single-centre randomised controlled trial (ABroProMida Study)"
EU CTIS ID: 2024-518820-65-00
What this study is testing
The main objective of this study is to assess and compare the safety and efficacy of two pharmacological regimens (Propofol + Petidine vs Midazolam + Petidine), administered independently by the medical staff of Pulmonology and RICU at San Donato Hospital in Arezzo to facilitate procedural sedation in patients undergoing bronchoscopic procedures.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of either sex aged > 18 years, capable of understanding and providing informed consent, scheduled for elective bronchoscopy, with or without echoendoscopy, for diagnostic/staging purposes or for therapeutic purposes.
You likely can't join if
- Patients unable to understand and sign informed consent; requiring urgent interventional procedures; with known hypersensitivity to the study drugs (propofol, pethidine, midazolam) or local anesthetics (such as lidocaine); with pre-existing haemodynamic instability or clinical conditions that could predispose them to instability during the procedure; with pre-existing compromised respiratory function prior to the procedure, including those on non-invasive ventilation (NIV), high-flow nasal cannula oxygen therapy (HFNC), those hospitalised for severe acute respiratory failure, and individuals on continuous home oxygen therapy (24 hours/day).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.