Prospective, randomized, double-blinded, placebo-controlled clinical study.
Operating room of a university hospital.
96 ASA physical status 1, 2, and 3 patients undergoing general anesthesia.
Patients were assigned to one of 6 treatment groups to receive IV midazolam (0.03 mg/kg) or placebo, followed 5 minutes later by one of three IV preinduction doses of lidocaine: 0.5, 1.0, or 1.5 mg/kg.
BIS values were recorded before administration of lidocaine and at 30-second intervals afterwards for three minutes. The primary endpoint was the average BIS level recorded.
Baseline BIS values were lower in the midazolam group (94 ¡À 4 vs. 90 ¡À 7, P < 0.001). There was no significant decrease in BIS values in the placebo group for any of the three lidocaine doses. However, in the midazolam groups, significant decreases in BIS levels versus baseline values were measured.
IV lidocaine decreases BIS in the presence of midazolam, suggesting that the effect of lidocaine on BIS is not direct, but rather results from modulation by midazolam.