Clinical trial • Phase IV • Respiratory

PROPOFOL for Sedation during medical procedure | Bronchoscopic procedure

Phase IV trial of PROPOFOL for Sedation during medical procedure | Bronchoscopic procedure.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Sedation during medical procedure | Bronchoscopic procedure
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-11-2024
First CTIS Authorization Date
20-03-2025

Trial design

Randomised, propofol + pethidine versus midazolam + pethidine; specific doses and schedules not specified in the provided ctis record.-controlled Phase IV trial across 1 site in Italy.

Randomised
Yes
Comparator
Propofol + Pethidine versus Midazolam + Pethidine; specific doses and schedules not specified in the provided CTIS record.
Target Sample Size
530

Eligibility

Recruits 530 No vulnerable populations selected; participants must be >18 years and capable of understanding and providing informed consent according to the inclusion criteria..

Vulnerable Population
No vulnerable populations selected; participants must be >18 years and capable of understanding and providing informed consent according to the inclusion criteria.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- 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)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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)..","definition_or_measurement_approach":"Desaturation defined as SpO2 < 90% for at least 30 seconds; comparison between treatment arms (Propofol+Pethidine vs Midazolam+Pethidine)."}

Secondary endpoints

  • {"endpoint_text":"- Adverse events (AEs); Procedural Tolerance using scores like the Aldrete score; Serious Adverse Events (SAE); Procedure Time; Final diagnostic yield.","definition_or_measurement_approach":"Adverse events and serious adverse events collected/reported; procedural tolerance assessed using scores such as the Aldrete score; procedure time measured in minutes; final diagnostic yield recorded as outcome of the procedure."}

Recruitment

Planned Sample Size
530
Recruitment Window Months
24
Consent Approach
Written informed consent required from participants capable of understanding and providing consent (>18 years). Subject information and informed consent forms are provided (documents in the record include English and Italian language forms and recruitment procedure documents).

Geography

Total Number Of Sites
1
Total Number Of Participants
530

Italy

Earliest CTIS Part Ii Submission Date
17-02-2025
Latest Decision Or Authorization Date
20-03-2025
Processing Time Days
31
Number Of Sites
1
Number Of Participants
530

Sites

Site Name
Ospedale Area Aretina Nord, Via Pietro Nenni 20/22
Department Name
Cardio Neuro Thoracic Vascular
Contact Person Name
Raffaele Scala

Sponsor

Primary sponsor

Full Name
Azienda Unita' Sanitaria Locale Toscana Sud Est
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
PROPOFOL
Active Substance
PROPOFOL
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised/marketed medicinal product (prodAuthStatus=2)
Maximum Dose
1.0 mg/kg/h (maxDailyDoseAmount)
Investigational Product Name
MIDAZOLAM
Active Substance
MIDAZOLAM
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised/marketed medicinal product (prodAuthStatus=2)
Maximum Dose
2 mg (maxDailyDoseAmount)
Investigational Product Name
PETHIDINE
Active Substance
PETHIDINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised/marketed medicinal product (prodAuthStatus=2)
Maximum Dose
0.5 mg/kg (maxDailyDoseAmount)
Combination Treatment
Yes

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