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NOT YET RECRUITING
NCT06736938
PHASE4

Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine

Sponsor: Fondazione Andrea Cesalpino Arezzo ONLUS

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

San Donato Hospital

Arezzo, Italy