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Starting soon Phase 4

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

NCT06736938 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Andrea Cesalpino Arezzo ONLUS
Phase
Phase 4
Started
2025-04-01
Last updated
2024-12-17

Condition(s) studied

Sedation During Bronchoscopy

Investigational drug(s) / intervention(s)

Propofol 1% →Midazolam →Pethidine →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients of either sex aged \> 18 years; 2. Patients able to understand and sign an informed consent to participation and data collection. 3. Patients who have to undergo bronchoscopy, with or without echendoscopy, scheduled in the election, for diagnostic - staging reasons (BL or BAL with microbiological research, endobronchial biopsies, transbronchial biopsies in EBUS/EUS, EBUS/EUS-TBNA ilo-mediastinal lymph node station). 4. Patients who must undergo bronchoscopy, scheduled as an elective, for therapeutic reasons (bronchial toilet, mechanical or laser-assisted airway recanalisation) Exclusion Criteria: 1. Patients unable to understand and sign an informed consent to participation and data collection. 2. Interventional procedures performed as a matter of urgency or without prior adequate time to clarify the methodology and objectives of the study. 3. Hypersensitivity to investigational drugs (propofol, pethidine, midazolam, local anaesthetics such as lidocaine). 4. Pre-existing haemodynamic instability or clinical conditions that may predispose to such instability during the procedure. This includes patients with acute coronary syndrome within the last 4-6 weeks, those requiring treatment with inotropes or vasoactive drugs to maintain a PAS\>90 mmHg, and patients with heart failure with reduced ejection fraction (FE \<40%), as defined by ESC guidelines. 5. Compromised respiratory exchanges already present before the procedure, including those requiring non-invasive ventilation (NIV), high-flow oxygen therapy via nasal cannulae (HFNC), those hospitalised for severe acute respiratory failure and patients on continuous home oxygen therapy (h24). This exclusion is necessary to avoid potential bias that could influence the study results and compromise their interpretation. 6. Inability to spontaneously protect the airways and manage bronchial secretions. 7. Pregnancy.

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)

FacilityCityRegionStatus
San Donato Hospital Arezzo Italy
Official registry record

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