Comparison of the pharmacokinetic profiles of three molecules of remifentanil in terms of hemodynamic response in laryngoscopy and tracheal intubation maneuvers
Abstract
Introduction: Several remifentanil products are commercialized in Colombia while these have never been compared in a clinical setting.
Objective: The aim of this study was to investigate the pharmacodynamic profile of the branded molecule of remifentanil (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 Contemporaneo, Argentina) registered in Colombia.
Methods: We 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 10 ng/ml with the Minto model. Induction was complemented with propofol 5 mcg/ml (TCI) with the Schneider model and rocuronium 0.6 mg/kg. The primary outcome was defined as the difference in mean arterial pressure and heart rate pre-intubation (TCI equilibrium) and post-intubation (maximum measurement within 5 minutes).
Results: A similar pharmacodinamic profile was observed between 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 against molecule O (beats/minute). The differences in the change in mean arterial pressure were 1 (95% CI: -4.81;6.81) for molecule A and 1.82 (95% CI: -4.08;7.74) for molecule B against molecule O (mmHg). There was a case of arterial hypotension in each group.
Conclusion: The 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 10 ng/ml.
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