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

Официальное название

Efficacy and Safety of Balanced Analgosedation in Bronchoscopy With Propofol/Pethidine Versus Midazolam/Pethidine: a Single-centre Randomised Controlled Trial

Обзор

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?

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Desaturation Index [Срок оценки: Trough study completion, an average of 2 years]

Вторичные конечные точки (7)

• Blood Pressure [Срок оценки: Trough study completion, an average of 2 years]
• Heart Rate [Срок оценки: Trough study completion, an average of 2 years]
• Respiratory Effects [Срок оценки: Trough study completion, an average of 2 years]
• Time in the recovery area [Срок оценки: Trough study completion, an average of 2 years]
• A postanesthetic recovery score (Aldrete) [Срок оценки: Trough study completion, an average of 2 years]
• Rapid On Site Evaluation results [Срок оценки: Trough study completion, an average of 2 years]
• Total desaturation time [Срок оценки: Trough study completion, an average of 2 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• San Donato Hospital — Arezzo

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06736938 · 20245188206500 · 2024-518820-65-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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