Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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?
Eligibility
Primary outcome measure(s)
- 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);
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| San Donato Hospital | Arezzo | Italy |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06736938 on ClinicalTrials.gov ↗ ← All trials in Italy