INTRODUCTION: No standardized sedation protocol is available for flexible bronchoscopy (FB). OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of three regimens used for sedation during FB. METHODS: This randomized double-blind controlled trial assessed patients undergoing bronchoscopy and receivinglidocaine alone (C) or combined with dexmedetomidine (D) or alfentanil (A). Tolerance was assessed using the bronchoscopy score, and level of sedation was assessed using the Nursing Instrument for the Communication of Sedation. Safety was evaluated in terms of pulmonary function and vital signs. RESULTS: A total of 162 patients were enrolled. The bronchoscopy score was identical in all groups. Group D subjects were the most sedated (P = .013), whereas group A subjects were the least agitated. Linear regression showed a negative association between bronchoscopy score and age in A (β = -0.06; P = .001). Positive predictors of bronchoscopy score were female gender (β = 1.96; P = .003) in D and obesity (β = 2.41; P = .012), longer procedures (β = 0.08; P = .009) and female gender (β = 1.15; P = .038) in C. Longer procedures (β = -0.12; P = .010) was a negative predictor of bronchoscopy score in D. Desaturation, hypoxia and heart rate changes were most prevalent in group A. Hypotension was mostly observed in D. CONCLUSIONS: No consistent differences were present between the three regimens; however, each was more appropriate in certain patient profiles. We consequently proposed a protocol as a first step towards standardizing sedation practice in FB in a patient-tailored manner. A more comprehensive and detailed protocol including other sedative agents with their corresponding doses should be developed.
RCT Entities:
INTRODUCTION: No standardized sedation protocol is available for flexible bronchoscopy (FB). OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of three regimens used for sedation during FB. METHODS: This randomized double-blind controlled trial assessed patients undergoing bronchoscopy and receiving lidocaine alone (C) or combined with dexmedetomidine (D) or alfentanil (A). Tolerance was assessed using the bronchoscopy score, and level of sedation was assessed using the Nursing Instrument for the Communication of Sedation. Safety was evaluated in terms of pulmonary function and vital signs. RESULTS: A total of 162 patients were enrolled. The bronchoscopy score was identical in all groups. Group D subjects were the most sedated (P = .013), whereas group A subjects were the least agitated. Linear regression showed a negative association between bronchoscopy score and age in A (β = -0.06; P = .001). Positive predictors of bronchoscopy score were female gender (β = 1.96; P = .003) in D and obesity (β = 2.41; P = .012), longer procedures (β = 0.08; P = .009) and female gender (β = 1.15; P = .038) in C. Longer procedures (β = -0.12; P = .010) was a negative predictor of bronchoscopy score in D. Desaturation, hypoxia and heart rate changes were most prevalent in group A. Hypotension was mostly observed in D. CONCLUSIONS: No consistent differences were present between the three regimens; however, each was more appropriate in certain patient profiles. We consequently proposed a protocol as a first step towards standardizing sedation practice in FB in a patient-tailored manner. A more comprehensive and detailed protocol including other sedative agents with their corresponding doses should be developed.
Authors: Elise Orvedal Leiten; Tomas Mikal Lind Eagan; Einar Marius Hjellestad Martinsen; Eli Nordeide; Gunnar Reksten Husebø; Kristel Svalland Knudsen; Sverre Lehmann; Øistein Svanes; Per Sigvald Bakke; Rune Nielsen Journal: BMJ Open Respir Res Date: 2020-03