"Efficacy and safety of Balanced Analgosedation in Bronchoscopy with Propofol/Pethidine versus Midazolam/Pethidine: a single-centre randomised controlled trial (ABroProMida Study)"

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518820-65-00

Acronym

ABroProMida

Enrollment

530

Registered

2025-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopic procedure with analgosedation for the diagnosis and management of various respiratory diseases.

Brief summary

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)..

Detailed description

Adverse events (AEs); Procedural Tolerance using scores like the Aldrete score; Serious Adverse Events (SAE); Procedure Time; Final diagnostic yield.

Interventions

DRUGPROPOFOL

DRUGMIDAZOLAM

DRUGPETHIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse events (AEs); Procedural Tolerance using scores like the Aldrete score; Serious Adverse Events (SAE); Procedure Time; Final diagnostic yield.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026