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Minerva anestesiologica · Oct 1999
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[Comparison of manual infusion of propofol and target-controlled infusion: effectiveness, safety and acceptability].
- B Mazzarella, C Melloni, S Montanini, G P Novelli, V A Peduto, E Santandrea, E Vincenti, and J Zattoni.
- Istituto di Anestesia e Rianimazione, Università degli Studi, Napoli.
- Minerva Anestesiol. 1999 Oct 1;65(10):701-9.
BackgroundDiprifusor 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.MethodsThis 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).ResultsInduction 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).ConclusionsThe TCI technique is effective and safe, and has a better acceptability than the manually controlled infusion technique.
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