Sedation During BronchoscopyPhase 4ABroProMidaNCT06736938
Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine
A Phase 4 study testing Propofol 1%, Midazolam and Pethidine in people with Sedation During Bronchoscopy, run by Fondazione Andrea Cesalpino Arezzo ONLUS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation During Bronchoscopy
- What is being tested?
- Propofol 1%, Midazolam and Pethidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 1 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged > 18 years;
- Patients able to understand and sign an informed consent to participation and data collection.
- 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).
- Patients who must undergo bronchoscopy, scheduled as an elective, for therapeutic reasons (bronchial toilet, mechanical or laser-assisted airway recanalisation)
Who cannot join
- Patients unable to understand and sign an informed consent to participation and data collection.
- Interventional procedures performed as a matter of urgency or without prior adequate time to clarify the methodology and objectives of the study.
- Hypersensitivity to investigational drugs (propofol, pethidine, midazolam, local anaesthetics such as lidocaine).
- 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.
- 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.
- Inability to spontaneously protect the airways and manage bronchial secretions.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
San Donato Hospital
Arezzo, 52100
Raffaele Scala, MD, +390575 254541, raffaele.scala@uslsudest.toscana.it
About this study
Official title: Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial
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?
Read the detailed description
Bronchoscopic procedures are essential in the diagnosis and management of various respiratory diseases, but they can cause significant discomfort for patients.
Analgosedation plays a crucial role in improving patient comfort while ensuring optimal conditions for the safe performance of the procedure. However, sedation management protocols can vary greatly depending on the hospital center and the availability of an anesthetist.
Over the years, with the increasing number of bronchoscopic procedures, the growing complexity of patients-particularly those with pulmonary diseases presenting comorbidities and significant gas exchange alterations-and the limited availability of anesthetists in national hospital facilities, there has been a growing reliance on independently managed procedural sedation.
This independent management-without the need for an anesthesia specialist-has been facilitated by the use of relatively easy-to-manage drugs like midazolam, a benzodiazepine (BDZ) with a pharmacokinetic profile that makes it preferable to other similar compounds due to its rapid onset of action and the availability of an antagonist capable of reversing its effects.
However, it is important to acknowledge that the use of midazolam carries significant risks.
Propofol, compared to midazolam, is characterized by an even faster onset of action, but more importantly by higher clearance and redistribution, allowing for rapid recovery of consciousness even after prolonged infusions. Nevertheless, this drug is also associated with adverse effects, particularly on cardiac inotropic and chronotropic function as well as mean arterial pressure, thus requiring caution in its administration.
The use of propofol-as per the technical data sheet approved by the Italian Medicines Agency (AIFA)-is reserved for doctors specialized in anesthesia or those experienced in the care of intensive care patients. Pulmonologists, with their specific training in respiratory function management, possess crucial skills in administering deep sedation, such as that induced by propofol, as patient safety largely depends on proper airway management during the procedure.
The Complex Operative Unit of Pneumology and RICU (Respiratory Intensive Care Unit) at San Donato Hospital in Arezzo has extensive experience in the field of procedural analgesia.
This study is driven by the need to generate scientific evidence supporting effective and safe alternatives for analgosedation managed by pulmonologists during bronchoscopic procedures. The aim is to consolidate and expand upon preliminary studies in the literature, with the goal of ensuring optimal sedation even in the absence of anesthesia assistance.
- Conditions
- Sedation During Bronchoscopy
- Being tested
- Propofol 1%, Midazolam, Pethidine
- Keywords
- Balanced Analgosedation, Pulmonologist, Propofol, MIdazolam, Petidhine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 1%Drug
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.
MidazolamDrug
Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.
PethidineDrug
Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Bronchoscopy | Active comparator | eg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS Receives: Drug: Propofol 1%; Drug: Midazolam; Drug: Pethidine |
| Non-bioptic Bronchoscopy | Active comparator | such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage. Receives: Drug: Propofol 1%; Drug: Midazolam; Drug: Pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation Index
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);
Measured: Trough study completion, an average of 2 years
Secondary outcomes (7)
Blood Pressure
This involves comparing the rates of peri- and post-procedural complications between the two treatment arms.
- Hypotension defined by a systolic blood pressure <90 mmHg or a diastolic blood pressure <50 mmHg.
- Hypotension requiring fluid therapy, vasoactive/inotropic therapy (yes or not).
Measured: Trough study completion, an average of 2 years
Heart Rate
This involves comparing the rates of peri- and post-procedural complications between the two treatment arms.
- Bradycardia defined as a rate <50 bpm requiring fluid therapy, vasoactive/inotropic therapy;
Measured: Trough study completion, an average of 2 years
Respiratory Effects
This involves comparing the rates of peri- and post-procedural complications between the two treatment arms.
- Respiratory effects: bronchospasm or wheezing requiring systemic corticosteroids, aerosolized or systemic bronchodilator therapy (e.g., beta agonists, magnesium sulphate).
Measured: Trough study completion, an average of 2 years
Time in the recovery area
Time spent in the recovery area (in minutes)
Measured: Trough study completion, an average of 2 years
A postanesthetic recovery score (Aldrete)
Patient recovery assessed by Aldrete score. It evaluates a patient's recovery after anesthesia based on five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored from 0 to 2, resulting in a total score ranging from 0 (minimum) to 10 (maximum).
Investigators will consider patient recovery achieved with an Aldrete score ≥9.
Measured: Trough study completion, an average of 2 years
Rapid On Site Evaluation results
i.e.: procedure with suitable sample (Yes or Not)
Measured: Trough study completion, an average of 2 years
Total desaturation time
Total desaturation time is defined as the cumulative time a patient's oxygen saturation (SpO2) falls below a predefined threshold (SpO2<90%) during the procedure.
Measured: Trough study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Sedation During BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients may undergo flexible bronchoscopy based solely on clinical indications, with procedures classified as either interventional (e.g., laser therapy, ndotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS) or non-bioptic procedures, such as bronchial lavage, bronchoalveolar lavage, or endobronchial lavage. To ensure a balanced distribution of characteristics that could influence study outcomes, stratified block randomisation will be used. Patients will be stratified according to the type of bronchoscopic procedure (interventional vs simple), as the complexity and invasiveness of the procedure may influence the required depth of sedation. Within each group, block randomisation with a 1:1 ratio will be applied to ensure a consistent balance of patients recruited between treatment groups (Propofol+Pethidine or Midazolam+Pethidine).
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Andrea Cesalpino Arezzo ONLUS
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Toscana Sud Est, Ospedale San Donato, Arezzo
- Responsible party
- Principal investigator, Raffaele Scala, Fondazione Andrea Cesalpino Arezzo ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736938
- Sponsor's protocol ID
- 20245188206500
- Other IDs
- 2024-518820-65-00
- Acronym
- ABroProMida
- Status last verified
- Dec 2024
- First submitted
- 9 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clarkson K, Power CK, O'Connell F, Pathmakanthan S, Burke CM. A comparative evaluation of propofol and midazolam as sedative agents in fiberoptic bronchoscopy. Chest. 1993 Oct;104(4):1029-31. doi: 10.1378/chest.104.4.1029.
PubMed 8404160Ozturk T, Cakan A, Gulerce G, Olgac G, Deren S, Ozsoz A. Sedation for fiberoptic bronchoscopy: fewer adverse cardiovascular effects with propofol than with midazolam. Anasthesiol Intensivmed Notfallmed Schmerzther. 2004 Oct;39(10):597-602. doi: 10.1055/s-2004-825919.
PubMed 15486802Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.
PubMed 19443532Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.
PubMed 22132138Roelandt P, Haesaerts R, Demedts I, Bisschops R. Implementation of the Aldrete score reduces recovery time after non-anesthesiologist-administered procedural sedation in gastrointestinal endoscopy. Endosc Int Open. 2022 Dec 15;10(12):E1544-E1547. doi: 10.1055/a-1964-7458. eCollection 2022 Dec.
PubMed 36531676Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743Allocca V, Guidelli L, Galgano A, Benedetti L, Fabbroni R, Bianco A, Paladini P, Scala R. Safety and Diagnostic Yield of Medical Pleuroscopy (MP) Performed under Balanced Analgosedation by a Pneumological Team Compared to Video-Assisted Thoracic Surgery (VATS): A Retrospective Controlled Real-Life Study (TORAPO). Diagnostics (Basel). 2024 Mar 7;14(6):569. doi: 10.3390/diagnostics14060569.
PubMed 38534990Maffucci R, Maccari U, Guidelli L, Benedetti L, Fabbroni R, Piccoli B, Bianco A, Scala R. Pulmonologist-Administered Balanced Propofol Analgosedation during Interventional Procedures: An Italian Real-Life Study on Comfort and Safety. Int J Clin Pract. 2022 Jun 13;2022:3368077. doi: 10.1155/2022/3368077. eCollection 2022.
PubMed 35814307Wang Z, Hu Z, Dai T. The comparison of propofol and midazolam for bronchoscopy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2018 Sep;97(36):e12229. doi: 10.1097/MD.0000000000012229.
PubMed 30200147Ebert TJ. Sympathetic and hemodynamic effects of moderate and deep sedation with propofol in humans. Anesthesiology. 2005 Jul;103(1):20-4. doi: 10.1097/00000542-200507000-00007.
PubMed 15983452Fabus MS, Sleigh JW, Warnaby CE. Effect of Propofol on Heart Rate and Its Coupling to Cortical Slow Waves in Humans. Anesthesiology. 2024 Jan 1;140(1):62-72. doi: 10.1097/ALN.0000000000004795.
PubMed 37801625Lichtenbelt BJ, Mertens M, Vuyk J. Strategies to optimise propofol-opioid anaesthesia. Clin Pharmacokinet. 2004;43(9):577-93. doi: 10.2165/00003088-200443090-00002.
PubMed 15217302Williams TJ, Bowie PE. Midazolam sedation to produce complete amnesia for bronchoscopy: 2 years' experience at a district general hospital. Respir Med. 1999 May;93(5):361-5. doi: 10.1016/s0954-6111(99)90320-7.
PubMed 10464905Zomorodi K, Donner A, Somma J, Barr J, Sladen R, Ramsay J, Geller E, Shafer SL. Population pharmacokinetics of midazolam administered by target controlled infusion for sedation following coronary artery bypass grafting. Anesthesiology. 1998 Dec;89(6):1418-29. doi: 10.1097/00000542-199812000-00020.
PubMed 9856717Somma J, Donner A, Zomorodi K, Sladen R, Ramsay J, Geller E, Shafer SL. Population pharmacodynamics of midazolam administered by target controlled infusion in SICU patients after CABG surgery. Anesthesiology. 1998 Dec;89(6):1430-43. doi: 10.1097/00000542-199812000-00021.
PubMed 9856718
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06736938
- Acronym / sponsor ID
- ABroProMida / 20245188206500
- Conditions
- Sedation During Bronchoscopy
- Keywords
- Balanced Analgosedation, Pulmonologist, Propofol, MIdazolam, Petidhine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Fondazione Andrea Cesalpino Arezzo ONLUSUniversity, hospital or other
- Collaborators
- Azienda USL Toscana Sud Est, Ospedale San Donato, Arezzo
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Bronchoscopic procedures are essential in the diagnosis and management of various respiratory diseases, but they can cause significant discomfort for patients.
Analgosedation plays a crucial role in improving patient comfort while ensuring optimal conditions for the safe performance of the procedure. However, sedation management protocols can vary greatly depending on the hospital center and the availability of an anesthetist.
Over the years, with the increasing number of bronchoscopic procedures, the growing complexity of patients-particularly those with pulmonary diseases presenting comorbidities and significant gas exchange alterations-and the limited availability of anesthetists in national hospital facilities, there has been a growing reliance on independently managed procedural sedation.
This independent management-without the need for an anesthesia specialist-has been facilitated by the use of relatively easy-to-manage drugs like midazolam, a benzodiazepine (BDZ) with a pharmacokinetic profile that makes it preferable to other similar compounds due to its rapid onset of action and the availability of an antagonist capable of reversing its effects.
However, it is important to acknowledge that the use of midazolam carries significant risks.
Propofol, compared to midazolam, is characterized by an even faster onset of action, but more importantly by higher clearance and redistribution, allowing for rapid recovery of consciousness even after prolonged infusions. Nevertheless, this drug is also associated with adverse effects, particularly on cardiac inotropic and chronotropic function as well as mean arterial pressure, thus requiring caution in its administration.
The use of propofol-as per the technical data sheet approved by the Italian Medicines Agency (AIFA)-is reserved for doctors specialized in anesthesia or those experienced in the care of intensive care patients. Pulmonologists, with their specific training in respiratory function management, possess crucial skills in administering deep sedation, such as that induced by propofol, as patient safety largely depends on proper airway management during the procedure.
The Complex Operative Unit of Pneumology and RICU (Respiratory Intensive Care Unit) at San Donato Hospital in Arezzo has extensive experience in the field of procedural analgesia.
This study is driven by the need to generate scientific evidence supporting effective and safe alternatives for analgosedation managed by pulmonologists during bronchoscopic procedures. The aim is to consolidate and expand upon preliminary studies in the literature, with the goal of ensuring optimal sedation even in the absence of anesthesia assistance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients may undergo flexible bronchoscopy based solely on clinical indications, with procedures classified as either interventional (e.g., laser therapy, ndotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS) or non-bioptic procedures, such as bronchial lavage, bronchoalveolar lavage, or endobronchial lavage. To ensure a balanced distribution of characteristics that could influence study outcomes, stratified block randomisation will be used. Patients will be stratified according to the type of bronchoscopic procedure (interventional vs simple), as the complexity and invasiveness of the procedure may influence the required depth of sedation. Within each group, block randomisation with a 1:1 ratio will be applied to ensure a consistent balance of patients recruited between treatment groups (Propofol+Pethidine or Midazolam+Pethidine).
| Arm | Type | Receives |
|---|---|---|
| Interventional Bronchoscopy | Active comparator | Drug: Propofol 1%, Drug: Midazolam, Drug: Pethidineeg., laser therapy, endotracheal/endobronchial debulking, visual biopsies, mucosal biopsies, or transbronchial biopsies guided by echo-endoscopy such as EBUS or EUS |
| Non-bioptic Bronchoscopy | Active comparator | Drug: Propofol 1%, Drug: Midazolam, Drug: Pethidinesuch as bronchial lavage, bronchoalveolar lavage or endobronchial lavage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either sex aged > 18 years;
- Patients able to understand and sign an informed consent to participation and data collection.
- 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).
- Patients who must undergo bronchoscopy, scheduled as an elective, for therapeutic reasons (bronchial toilet, mechanical or laser-assisted airway recanalisation)
Key exclusion criteria (7 listed)
- Patients unable to understand and sign an informed consent to participation and data collection.
- Interventional procedures performed as a matter of urgency or without prior adequate time to clarify the methodology and objectives of the study.
- Hypersensitivity to investigational drugs (propofol, pethidine, midazolam, local anaesthetics such as lidocaine).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Interventional Bronchoscopy, Non-bioptic Bronchoscopy |
| MidazolamMidazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg. | Drug | Interventional Bronchoscopy, Non-bioptic Bronchoscopy |
| PethidinePethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg. | Drug | Interventional Bronchoscopy, Non-bioptic Bronchoscopy |
Primary outcome
Desaturation Index
Time frame: 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);
7 secondary outcomes
Blood Pressure
Time frame: Trough study completion, an average of 2 years
Heart Rate
Time frame: Trough study completion, an average of 2 years
Respiratory Effects
Time frame: Trough study completion, an average of 2 years
Time in the recovery area
Time frame: Trough study completion, an average of 2 years
A postanesthetic recovery score (Aldrete)
Time frame: Trough study completion, an average of 2 years
Rapid On Site Evaluation results
Time frame: Trough study completion, an average of 2 years
Total desaturation time
Time frame: Trough study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Results publication: PubMed 8404160Clarkson K, Power CK, O'Connell F, Pathmakanthan S, Burke CM. A comparative evaluation of propofol and midazolam as sedative agents in fiberoptic bronchoscopy. Chest. 1993 Oct;104(4):1029-31. doi: 10.1378/chest.104.4.1029.
- Results publication: PubMed 15486802Ozturk T, Cakan A, Gulerce G, Olgac G, Deren S, Ozsoz A. Sedation for fiberoptic bronchoscopy: fewer adverse cardiovascular effects with propofol than with midazolam. Anasthesiol Intensivmed Notfallmed Schmerzther. 2004 Oct;39(10):597-602. doi: 10.1055/s-2004-825919.
- Results publication: PubMed 19443532Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.
- Results publication: PubMed 22132138Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.
- Results publication: PubMed 36531676Roelandt P, Haesaerts R, Demedts I, Bisschops R. Implementation of the Aldrete score reduces recovery time after non-anesthesiologist-administered procedural sedation in gastrointestinal endoscopy. Endosc Int Open. 2022 Dec 15;10(12):E1544-E1547. doi: 10.1055/a-1964-7458. eCollection 2022 Dec.
- Results publication: PubMed 12421743Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
- Results publication: PubMed 38534990Allocca V, Guidelli L, Galgano A, Benedetti L, Fabbroni R, Bianco A, Paladini P, Scala R. Safety and Diagnostic Yield of Medical Pleuroscopy (MP) Performed under Balanced Analgosedation by a Pneumological Team Compared to Video-Assisted Thoracic Surgery (VATS): A Retrospective Controlled Real-Life Study (TORAPO). Diagnostics (Basel). 2024 Mar 7;14(6):569. doi: 10.3390/diagnostics14060569.
- Results publication: PubMed 35814307Maffucci R, Maccari U, Guidelli L, Benedetti L, Fabbroni R, Piccoli B, Bianco A, Scala R. Pulmonologist-Administered Balanced Propofol Analgosedation during Interventional Procedures: An Italian Real-Life Study on Comfort and Safety. Int J Clin Pract. 2022 Jun 13;2022:3368077. doi: 10.1155/2022/3368077. eCollection 2022.
- Results publication: PubMed 30200147Wang Z, Hu Z, Dai T. The comparison of propofol and midazolam for bronchoscopy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2018 Sep;97(36):e12229. doi: 10.1097/MD.0000000000012229.
- Results publication: PubMed 15983452Ebert TJ. Sympathetic and hemodynamic effects of moderate and deep sedation with propofol in humans. Anesthesiology. 2005 Jul;103(1):20-4. doi: 10.1097/00000542-200507000-00007.
- Results publication: PubMed 37801625Fabus MS, Sleigh JW, Warnaby CE. Effect of Propofol on Heart Rate and Its Coupling to Cortical Slow Waves in Humans. Anesthesiology. 2024 Jan 1;140(1):62-72. doi: 10.1097/ALN.0000000000004795.
- Results publication: PubMed 15217302Lichtenbelt BJ, Mertens M, Vuyk J. Strategies to optimise propofol-opioid anaesthesia. Clin Pharmacokinet. 2004;43(9):577-93. doi: 10.2165/00003088-200443090-00002.
- Individual participant dataSharing planned: No
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Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol 1%, Midazolam and Pethidine in people with Sedation During Bronchoscopy, run by Fondazione Andrea Cesalpino Arezzo ONLUS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Scala, MD (+390575 254541, raffaele.scala@uslsudest.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation Index (time frame: Trough study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736938, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.