[Comparison of manual infusion of propofol and target-controlled infusion: effectiveness, safety and acceptability].

BACKGROUND: Diprifusor TCI is a newly developed target-controlled system for the infusion of propofol. Purpose of this study is to evaluate the acceptability, efficacy and safety of Diprifusor TCI in comparison with the manually controlled technique. METHODS: This multicentre, randomised, parallel group study was carried out in 160 patients undergoing surgical procedures of 10 min to 4 h duration in 8 centres. In each centre 20 male or female patients, aged > or = 18 years, ASA I-III were randomised to treatment with either Diprifusor TCI (TCI group--80 patients) or manually controlled infusion (MI group--80 patients). Assessments included hemodynamics; adverse events, including accidents, actual or possible; recovery times; anesthetist ratings of quality of induction and maintenance, and of ease of control and use of technique. Ratings were summed up in a global quality score (study end-point). RESULTS: Induction doses were significantly lower (median values 1.4 vs 1.9 mg/kg) and maintenance infusion rate significantly higher (median values 10.2 vs 8.8 mg/kg/h) in the TCI group; anesthetists ratings obtained maximum scores in most patients of either group, but more frequently in the TCI group, with significant differences for ease of control (good 91.2% TCI vs 74.7% IM; adequate 8.8 vs 21.5%; poor 0 vs 3.8%), and of use of technique (good 91.2% TCI vs 60.8% IM; adequate 8.8 vs 39.2%); the global quality score showed a significant advantage for the TCI system (median value 12 vs 11). CONCLUSIONS: The TCI technique is effective and safe, and has a better acceptability than the manually controlled infusion technique.