Another potentially disturbing complication where neuromuscular blockade is employed is ' anesthesia awareness '. In this situation, patients paralyzed may awaken during their anesthesia, due to an inappropriate decrease in the level of drugs providing sedation and/or pain relief. If this fact is missed by the anesthesia provider, the patient may be aware of their surroundings, but be incapable of moving or communicating that fact. Neurological monitors are increasingly available that may help decrease the incidence of awareness. Most of these monitors use proprietary algorithms monitoring brain activity via evoked potentials. Despite the widespread marketing of these devices many case reports exist in which awareness under anesthesia has occurred despite apparently adequate anesthesia as measured by the neurologic monitor. [ citation needed ]
The incidence of common adverse events in Table 1 below is based upon pooled data from three 12-week, double-blind, placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated with 2 inhalations of Symbicort 80/ or Symbicort 160/ twice daily. The Symbicort group was composed of mostly Caucasian (84%) patients with a mean age of 38 years, and a mean percent predicted FEV 1 at baseline of 76 and 68 for the 80/ mcg and 160/ mcg treatment groups, respectively. Control arms for comparison included 2 inhalations of budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) mcg, or placebo (MDI and DPI) twice daily. Table 1 includes all adverse events that occurred at an incidence of > 3% in any one Symbicort group and more commonly than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of patient exposure for Symbicort patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.