Propofol versus midazolam in medical thoracoscopy: a randomized, noninferiority trial.

BACKGROUND Hypoxemia is a surrogate marker for periprocedural endoscopic complications. There are no data comparing the safety of propofol sedation with another sedative regimen in medical thoracoscopy. OBJECTIVE To evaluate whether sedation with propofol is as safe and effective as sedation with midazolam. METHODS Ninety consecutive patients undergoing medical thoracoscopy were randomly allocated to receive either intravenous propofol or midazolam. Predefined periprocedural complications included hypoxemia, hypotension, bleeding, need for airway insertion, mechanical ventilation, intensive care unit transfer and death. The primary endpoint was the mean lowest oxygen saturation during the procedure. RESULTS Randomized groups had similar demographics (64 ± 16 years, 57% male, 91% American Society of Anesthesiologists class III-IV) and a balanced distribution of procedures. The mean lowest oxygen saturation during the procedure was significantly lower in the propofol group as compared to the midazolam group (93 ± 6 vs. 96 ± 3%, p = 0.007). Patients randomized to propofol showed more episodes of hypoxemia (27 vs. 4%, p = 0.007) and hypotension (82 vs. 40%, p < 0.0001). No procedure had to be aborted. None of the patients required an artificial airway, mechanical ventilation or intensive care unit care, and none died. CONCLUSIONS As assessed by the surrogate marker hypoxemia, propofol should not be considered the first choice for sedation in medical thoracoscopy.