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

NCT06736938 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 202451882065002024-518820-65-00
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Sedation During Bronchoscopy

Keywords

Balanced Analgosedation; Pulmonologist; Propofol; MIdazolam; Petidhine

Outcome Measures

Primary Outcomes (1)

• 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);

  Trough study completion, an average of 2 years

Secondary Outcomes (7)

• Blood Pressure

  Trough study completion, an average of 2 years

• Heart Rate

  Trough study completion, an average of 2 years

• Respiratory Effects

  Trough study completion, an average of 2 years

• Time in the recovery area

  Trough study completion, an average of 2 years

• A postanesthetic recovery score (Aldrete)

  Trough study completion, an average of 2 years

Study Arms (2)

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

Drug: Propofol 1%; Drug: Midazolam; Drug: Pethidine

Non-bioptic Bronchoscopy

ACTIVE COMPARATOR

such as bronchial lavage, bronchoalveolar lavage or endobronchial lavage.

Drug: Propofol 1%; Drug: Midazolam; Drug: Pethidine

Interventions

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.

Interventional Bronchoscopy; Non-bioptic Bronchoscopy

Midazolam DRUG

Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.

Interventional Bronchoscopy; Non-bioptic Bronchoscopy

Pethidine DRUG

Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.

Interventional Bronchoscopy; Non-bioptic Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Inability to spontaneously protect the airways and manage bronchial secretions.
• Pregnancy.

Sponsors & Collaborators

• Fondazione Andrea Cesalpino Arezzo ONLUS: lead
• Azienda USL Toscana Sud Est: collaborator
• Ospedale San Donato, Arezzo: collaborator

Study Sites (1)

San Donato Hospital

Arezzo, 52100, Italy

Location

Related Publications (20)

• 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.

  PMID: 8404160 RESULT

• Ozturk 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.

  PMID: 15486802 RESULT

• Clark 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.

  PMID: 19443532 RESULT

• Lo 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.

  PMID: 22132138 RESULT

• Roelandt 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.

  PMID: 36531676 RESULT

• Sessler 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.

  PMID: 12421743 RESULT

• Allocca 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.

  PMID: 38534990 RESULT

• Maffucci 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.

  PMID: 35814307 RESULT

• Wang 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.

  PMID: 30200147 RESULT

• Ebert 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.

  PMID: 15983452 RESULT

• Fabus 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.

  PMID: 37801625 RESULT

• Lichtenbelt BJ, Mertens M, Vuyk J. Strategies to optimise propofol-opioid anaesthesia. Clin Pharmacokinet. 2004;43(9):577-93. doi: 10.2165/00003088-200443090-00002.

  PMID: 15217302 RESULT

• Williams 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.

  PMID: 10464905 RESULT

• Zomorodi 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.

  PMID: 9856717 RESULT

• Somma 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.

  PMID: 9856718 RESULT

• Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.

  PMID: 23860341 RESULT

• Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.

  PMID: 22045879 RESULT

• Baughman RP, Dohn MN, Loudon RG, Frame PT. Bronchoscopy with bronchoalveolar lavage in tuberculosis and fungal infections. Chest. 1991 Jan;99(1):92-7. doi: 10.1378/chest.99.1.92.

  PMID: 1898648 RESULT

• Lachant DJ, Croft DP, McGrane Minton H, Hardy DJ, Prasad P, Kottmann RM. The clinical impact of pneumocystis and viral PCR testing on bronchoalveolar lavage in immunosuppressed patients. Respir Med. 2018 Dec;145:35-40. doi: 10.1016/j.rmed.2018.10.021. Epub 2018 Oct 22.

  PMID: 30509714 RESULT

• Postmus PE. Bronchoscopy for lung cancer. Chest. 2005 Jul;128(1):16-8. doi: 10.1378/chest.128.1.16. No abstract available.

  PMID: 16002910 RESULT

MeSH Terms

Interventions

Propofol; Midazolam; Meperidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Raffaele Scala, MD

CONTACT

+390575 254541; raffaele.scala@uslsudest.toscana.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of COU Pulmonology and RICU - San Donato Hospital

Model Details: 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).

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: December 17, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)