Comparison of the pharmacodynamic profiles of three molecules of remifentanil in terms of hemodynamic response to laryngoscopy and tracheal intubation maneuvers

Abstract

IntroductionSeveral remifentanil products are commercialized in Colombia though they have never been compared in a clinical setting. ObjectiveThe aim of this study was to investigate the pharmacodynamic profile of the branded remifentanil molecule (group O: Glaxo SmithKline Manufacturing S.P.A.) and two unbranded molecules (group A: Laboratorios Chalver de Colombia S.A. and group B: Instituto Biológico Contemporáneo, Argentina) registered in Colombia. MethodsWe carried out a double-blind, randomized, controlled trial. The branded molecule of remifentanil (group O, n=29) was compared with the two unbranded molecules (group A, n=29; group B, n=32) during anesthetic induction and tracheal intubation in adult patients ASA I without predictors for difficult airway. The target controlled infusion (TCI) doses evaluated were 6, 8 and 10ng/ml with the Minto model. Induction was complemented with propofol 5mcg/ml (TCI) with the Schneider model and rocuronium 0.6mg/kg. The primary outcome was the difference between preintubation (TCI equilirium) and postintubation (maximum measurement within 5min) mean arterial pressure and heart rate. ResultsA similar pharmacodynamic profile was observed in all of the studied remifentanil molecules. The differences in the change in heart rate were 1.27 (95% CI −3.11;5.67) with molecule A and 1.40 (95% CI −2.65;5.46) with molecule B compared to molecule O (beats/min). The differences in the change in mean arterial pressure were 1 (95% CI -4.81;6.81) with molecule A and 1.82 (95% CI −4.08;7.74) with molecule B compared to molecule O (mmHg). There was one case of arterial hypotension in each group. ConclusionThe results suggest that, from a pharmacodynamic point of view, branded and unbranded remifentanil molecules are similar for laryngoscopy/intubation with TCI doses 6, 8 and 10ng/ml.