Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA

Summary

Background: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure for diagnosing and staging mediastinal lymph node lesions in lung cancer. Adequate sedation is crucial for patient comfort and diagnostic accuracy. Different sedation modalities, including moderate sedation/conscious sedation, deep sedation, and general anesthesia, are utilized. This study aims to evaluate patient comfort and satisfaction levels of healthcare providers (bronchoscopists and anesthesiologists) when administering remifentanil through Target Controlled Infusion (TCI) for conscious sedation during EBUS-TBNA. A prospective randomized study design compares this approach to the standard sedation protocol involving midazolam, fentanyl, and/or propofol. Methods: this study will enroll 30 eligible patients randomly divided into two groups. Group 1, "REMIFENTANIL TCI", underwent EBUS-TBNA under conscious sedation with remifentanil TCI infusion targeting a concentration of 3-6 ng/ml. Group 2, "STANDARD", received conscious sedation with a combination of midazolam, fentanyl, and/or propofol administered in boluses based on clinical requirements. Complications, safety, and satisfaction levels of the operator, anesthesiologist, and patients will be evaluated.

Timeline

Start

2021-09-20

Primary completion

2022-07-01

Completion

2023-01-17

Publications

• 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 Aswanetmanee P, Limsuwat C, Kabach M, Alraiyes AH, Kheir F. The role of sedation in endobronchial ultrasound-guided transbronchial needle aspiration: Systematic review. Endosc Ultrasound. 2016 Sep-Oct;5(5):300-306. doi: 10.4103/2303-9027.191608.
• Results Scarlata S, Costa F, Pascarella G, Strumia A, Antonelli Incalzi R, Agro FE. Remifentanil Target-Controlled Infusion for Conscious Sedation in Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Case Series. Clin Drug Investig. 2020 Oct;40(10):985-988. doi: 10.1007/s40261-020-00960-0. No abstract available.

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