Remifentanil Target-controlled Infusion Versus Standard of Care for Conscious Sedation During Ultrasound-guided Transbronchial Needle Aspiration and Biopsy: A Randomized, Prospective, Control Study.

Abstract

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure that has become an important tool in the diagnosis and staging of mediastinal lymph node lesions in lung cancer. Adequate sedation is an important part of the procedure as it provides patient comfort and potentially increases diagnostic yield. The sedation modality varies among centers and includes moderate sedation/conscious sedation, deep sedation, and general anesthesia. The object of this study will be the evaluation of patient's comfort and level of satisfaction with the involved health care providers (bronchoscopist and anesthesiologist) of remifentanil administration in target-controlled infusion (TCI) for conscious sedation in patients undergoing EBUS‑TBNA, with a prospective randomized study design versus the of standard sedation protocol with midazolam and/or fentanest and/or propofol. This study was carried out at the "Campus Biomedico di Roma" University Hospital between September 2021 and November 2021, with a total number of 30 patients enrolled who met the eligibility criteria, randomly divided into 2 groups: group 1 "REMIFENTANIL TCI" (experimental group) where the patients performed the EBUS-TBNA procedure under conscious sedation with infusion of remifentanil TCI with a target between 3 ng/mL and 6ng/mL and group 2 "STANDARD" (control group) with patients undergoing conscious sedation with the association of midazolam and/or fentanest and/or propofol in refracted boluses based on clinical needs. Complications, safety, and level of satisfaction of the operator, the anesthesiologist, and the patient were evaluated. The results show that sedation with remifentanil in TCI can improve the comfort level of patients, reducing the risks associated with the procedure (lower frequency of oversedations and hypotension), allowing for greater intraprocedural safety. Furthermore, the level of satisfaction of the anesthesiologist and that of the operator appears to be significantly higher in the Remifentanil group. The execution of a mild to moderate sedation with Remifentanil in TCI in patients undergoing EBUS is safe, tolerated, and allows to obtain greater intraprocedural comfort. Further studies and larger and more representative samples are obviously needed to confirm and strengthen the validity of a remifentanil TCI-based sedation in endoscopic diagnostics.