drugset / Trial / NCT06736938
Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine
Phase 4
Not yet recruiting
530 enrolled
Fondazione Andrea Cesalpino Arezzo ONLUS
Azienda USL Toscana Sud Est · collabOspedale San Donato, Arezzo · collab
RandomizedParallel-groupOpen-labelOther
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?
Timeline
- Start
- 2025-04-01
- Primary completion
- 2027-04-01
- Completion
- 2027-04-01
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Postmus PE. Bronchoscopy for lung cancer. Chest. 2005 Jul;128(1):16-8. doi: 10.1378/chest.128.1.16. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Meperidine | Unknown | 0.5 mg/kg | Intravenous |
| Comparator | Midazolam | Small molecule | 0.5 mg | Intravenous |
| Comparator | Midazolam | Small molecule | 1 mg | Intravenous |
| Comparator | Propofol | Small molecule | 0.5 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 1 mg/kg | Intravenous |
Indications
No indication recorded.