2024-518820-65-00
Withdrawn
Phase 4
"Efficacy and safety of Balanced Analgosedation in Bronchoscopy with Propofol/Pethidine versus Midazolam/Pethidine: a single-centre randomised controlled trial (ABroProMida Study)"
Azienda Unita' Sanitaria Locale Toscana Sud Est1 site in 1 country530 target enrollmentStarted: March 20, 2025Last updated:
Overview
- Phase
- Phase 4
- Status
- Withdrawn
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- The primary endpoint of our study is to evaluate and compare the desaturation index (SpO2 < 90% for at least 30 seconds) between the two drug regimens (Propofol+Petidine vs Midazolam+Petidine)..
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
The primary endpoint of our study is to evaluate and compare the desaturation index (SpO2 < 90% for at least 30 seconds) between the two drug regimens (Propofol+Petidine vs Midazolam+Petidine)..
The primary endpoint of our study is to evaluate and compare the desaturation index (SpO2 < 90% for at least 30 seconds) between the two drug regimens (Propofol+Petidine vs Midazolam+Petidine)..
Secondary Outcomes
- Adverse events (AEs); Procedural Tolerance using scores like the Aldrete score; Serious Adverse Events (SAE); Procedure Time; Final diagnostic yield.
Investigators
Valentina Fabbrini
Scientific
Azienda Unita' Sanitaria Locale Toscana Sud Est
Study Sites (1)
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