A randomized, prospective double-blind comparison of the efficacy of generic propofol (sulphite additive) with Diprivan®

Background and objective: We compared the dose requirement and side effect profile of total intravenous anaesthesia using Diprivan (R) to generic propofol at a specific anaesthetic target level utilizing the bispectral index monitor to determine efficacy differences between the two products. Methods: Sixty women undergoing abdominal hysterectomy were induced with propofol 2 mg kg(-1) and maintained with infusion (20-200 mu g kg(-1) min(-1)) adjusted to maintain a bispectral index of 50-65. Plasma propofol concentration was measured at 1 and 2 h post induction in 25 patients. Results: Mean (SD) drug doses adjusted for weight and time were similar in the Diprivan (R) and generic propofol groups: 90 (30) mu g kg(-1) min(-1) vs. 90 (20) mu g kg(-1) min(-1) respectively. Mean (SD) plasma propofol levels at 1 and 2 h were also similar (3-0 (1-0) mu g mL(-1) vs. 3.6 (1.4) mu g mL(-1), P = 0.2 and 3.0 (1.9) mu g mL(-1) vs. 3.4 (1.6) mu g mL(-1), P = 0.58). Conclusions: Diprivan and generic propofol have similar efficacy at a specified, bispectral index-defined, depth of anaesthesia.