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Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine
Sponsor: Fondazione Andrea Cesalpino Arezzo ONLUS
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?
Official title: Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
530
Start Date
2025-04-01
Completion Date
2027-04-01
Last Updated
2024-12-17
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Pethidine
Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.
Locations (1)
San Donato Hospital
Arezzo, Italy