PURPOSE: The role of Midazolam (a short-acting benzodiazepine), in the flexible bronchoscopy premedication is debated. Indeed, there is evidence that sedative medications increase the tolerability of the procedure; does not change diagnostic yield of the procedure and is associated with increased side effects especially in the elderly. Aim: to evaluate whether Midazolam premedication increases the patient-reported tolerability and the physician-reported feasibility of the fiberoptic bronchoscopy.
METHODS: Study design: randomised, double-blinded, placebo controlled, three-arm study. Study population included patients, aged 18 - 70 y/o, who underwent diagnostic bronchoscopy for appropriate clinical indications. Patients were randomly assigned to receive: 0.035 mg/Kg intravenous Midazolam (Group A), 0.07 mg/Kg (Group B) or Placebo (Group C). Blood pressure and oxygen saturation were monitored in continuum during the procedure. At the end of the bronchoscopy the physician who performed the procedure filled a questionnaire to score procedure-related outcomes (satisfaction, feasibility, completeness and unexpected events). Patients were asked to fill a specific questionnaire to assess patient-reported tolerability and satisfaction 2 hr after the bronchoscopy. Ethical approval was obtained and patients provided written informed consent.
RESULTS: Results: 100 patients (mean age 63±2.1, male 58%) were included in the study (34 in group A, 33 in group B and 33 in group C). The three groups were matched for age and sex. Patient-reported tolerability score was significantly higher in group B (but not A) compared to C (p<0.01). No differences were found in the three groups in term of physician-reported feasibility of the procedure. In group A and B (but not in group C) significant oxygen desaturations were recorded compared to baseline at 10 and 8 minutes, respectively (p<0.01).
CONCLUSIONS: The use of Midazolam was associated with increased patient’s tolerability but had no effect on physician-reported feasibility of the bronchoscopy and was associated with significant reduction in oxygen saturation during the procedure.
CLINICAL IMPLICATIONS: The use of midazolam improves tolerability, has not affect on procedure-related outcomes and it has a satisfactory safety profile in patients undergoing flexible bronchoscopy.
DISCLOSURE: The following authors have nothing to disclose: Franco Ravenna, Marco Contoli, Elisabetta Marangoni, Cristiana Romanazzi, Giulia Gnesini, Denise Artioli, Caterina Ravenna, Alberto Papi
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