Overview
Sponsor-declared trial summary
Bronchoscopic procedure with analgosedation for the diagnosis and management of various respiratory diseases.
The main objective of this study is to assess and compare the safety and efficacy of two pharmacological regimens (Propofol + Petidine vs Midazolam + Petidine), administered independently by the medical staff of Pulmonology and RICU at San Donato Hospital in Arezzo to facilitate procedural sedation in patients undergoi…
Key facts
- Sponsor
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2025-03-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
The main objective of this study is to assess and compare the safety and efficacy of two pharmacological regimens (Propofol + Petidine vs Midazolam + Petidine), administered independently by the medical staff of Pulmonology and RICU at San Donato Hospital in Arezzo to facilitate procedural sedation in patients undergoing bronchoscopic procedures.
Secondary objectives 1
- Secondary objectives include evaluating and comparing peri- and post-procedural complications, such as cardiovascular and respiratory adverse events, as well as drug reactions. Additional metrics include procedural tolerance, procedure duration, average drug dosage, and final diagnostic outcomes of the procedures performed.
Conditions and MedDRA coding
Bronchoscopic procedure with analgosedation for the diagnosis and management of various respiratory diseases.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10049124 | Sedation during medical procedure | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 1
- Adverse events (AEs); Procedural Tolerance using scores like the Aldrete score; Serious Adverse Events (SAE); Procedure Time; Final diagnostic yield.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SCP112629113 · ATC
- Active substance
- Dobutamine Hydrochloride
- Route of administration
- INFUSION
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12567341 · ATC
- Active substance
- Pethidine Hydrochloride
- Substance synonyms
- MEPERIDINE HYDROCHLORIDE
- Route of administration
- INFUSION
- Max daily dose
- 0.5 mg/kg milligram(s)/kilogram
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AB02 — PETHIDINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12667971 · ATC
- Active substance
- Propofol
- Substance synonyms
- 2,6-Bis(PROPAN-2-YL)PHENOL, ICI-35868, DISOPROFOL
- Route of administration
- INFUSION
- Max daily dose
- 1.0 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 4.0 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Unita' Sanitaria Locale Toscana Sud Est
- Sponsor organisation
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Address
- Via Curtatone 54
- City
- Arezzo
- Postcode
- 52100
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Contact name
- Valentina Fabbrini
Public contact point
- Organisation
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Contact name
- Valentina Fabbrini
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Not authorised | 530 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | STUDY PROTOCOL EN for publication | 3.0 |
| Protocol (for publication) | Track Changes for publication Protocol eng | 3.0 |
| Protocol (for publication) | Track changes For publication Study protocol eng Vers2 of 11Feb25 | 2.0 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en | 1 |
| Subject information and informed consent form (for publication) | For publication Track Changes 13Febb25Modulo consenso adulti CCN | 2.0 |
| Subject information and informed consent form (for publication) | For publication Track Changes 13Febb25Modulo informativa autorizzazione dati personali | 2.0 |
| Subject information and informed consent form (for publication) | INFORMATIVA MMG for publication | 1 |
| Subject information and informed consent form (for publication) | Modulo informativa autorizzazione dati personali for publication | 2.0 |
| Subject information and informed consent form (for publication) | Modulo_consenso_adulti_CCN | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Midazolam hameln SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pethidine SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Product Monograph DIPRIVAN | 451094F |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_000141_036914 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_002829_036849 | 2.00 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_002838_035325 | 1 |
| Synopsis of the protocol (for publication) | SINOSSI PROTOCOLLO EN for publication | 1 |
| Synopsis of the protocol (for publication) | SINOSSI PROTOCOLLO IT for publication | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-15 | Italy | Not acceptable 2025-03-17
|
2025-03-20 |