BACKGROUND: The role of midazolam in flexible bronchoscopy premedication has been debated. The aim of the present study was to evaluate whether midazolam premedication increases the patient-reported tolerance and the physician-reported or nurse-reported feasibility of bronchoscopy. METHODS: Randomized, double-blinded, placebo-controlled, 3-arm study. The study population included patients undergoing bronchoscopy for appropriate clinical indications. Patients were randomly assigned to receive 0.035 mg/kg intravenous midazolam (low dose), 0.07 mg/kg (high dose), or placebo. Vital parameters were monitored in continuum during the procedure. At the end of the procedure, the operating physician and assisting nurse filled out a questionnaire to score the procedure-related outcomes (satisfaction, feasibility, completeness, and unexpected events). Patients were asked to fill out a specific questionnaire to assess the patient-reported tolerance and satisfaction 2 hours after the bronchoscopy. RESULTS: A total of 100 patients (mean age 58.6±1.0; 57% male) were included in the study (33 in the low-dose midazolam group, 34 in the high-dose midazolam group, and 33 in the placebo group). The patient-reported tolerance score was significantly higher in the high-dose midazolam group than in the placebo group (P<0.01). No differences were found in the 3 groups in terms of the physician-reported feasibility and completeness of the procedure. In the groups of patients premedicated with midazolam, significant oxygen desaturation was recorded (at 10 and 8 min after the introduction of the bronchoscope) compared with the baseline value (P<0.01). CONCLUSIONS: In our study, premedication with midazolam increased the patient-reported tolerance of the bronchoscopy. However, the absence of premedication did not affect the diagnostic yield of the procedure.
RCT Entities:
BACKGROUND: The role of midazolam in flexible bronchoscopy premedication has been debated. The aim of the present study was to evaluate whether midazolam premedication increases the patient-reported tolerance and the physician-reported or nurse-reported feasibility of bronchoscopy. METHODS: Randomized, double-blinded, placebo-controlled, 3-arm study. The study population included patients undergoing bronchoscopy for appropriate clinical indications. Patients were randomly assigned to receive 0.035 mg/kg intravenous midazolam (low dose), 0.07 mg/kg (high dose), or placebo. Vital parameters were monitored in continuum during the procedure. At the end of the procedure, the operating physician and assisting nurse filled out a questionnaire to score the procedure-related outcomes (satisfaction, feasibility, completeness, and unexpected events). Patients were asked to fill out a specific questionnaire to assess the patient-reported tolerance and satisfaction 2 hours after the bronchoscopy. RESULTS: A total of 100 patients (mean age 58.6±1.0; 57% male) were included in the study (33 in the low-dose midazolam group, 34 in the high-dose midazolam group, and 33 in the placebo group). The patient-reported tolerance score was significantly higher in the high-dose midazolam group than in the placebo group (P<0.01). No differences were found in the 3 groups in terms of the physician-reported feasibility and completeness of the procedure. In the groups of patients premedicated with midazolam, significant oxygen desaturation was recorded (at 10 and 8 min after the introduction of the bronchoscope) compared with the baseline value (P<0.01). CONCLUSIONS: In our study, premedication with midazolam increased the patient-reported tolerance of the bronchoscopy. However, the absence of premedication did not affect the diagnostic yield of the procedure.
Authors: Roberta Roncarati; Laura Lupini; Elena Miotto; Elena Saccenti; Susanna Mascetti; Luca Morandi; Cristian Bassi; Debora Rasio; Elisa Callegari; Valentina Conti; Rosa Rinaldi; Giovanni Lanza; Roberta Gafà; Alberto Papi; Antonio Frassoldati; Silvia Sabbioni; Franco Ravenna; Gian L Casoni; Massimo Negrini Journal: Mol Oncol Date: 2020-06-24 Impact factor: 6.603