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2019, Number 1

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Rev Cubana Farm 2019; 52 (1)

Comparison of the pharmacodynamic profiles of generic and innovator rocuronium in patients undergoing endotracheal intubation

Uribe MSL, Caraballo MR, Alviz AAA
Full text How to cite this article

Language: Spanish
References: 21
Page: 1-11
PDF size: 390.37 Kb.


Key words:

rocuronium, neuromuscular relaxants, intubation, generic drug.

ABSTRACT

Introduction: Rocuronium is an intermediate-acting, non-depolarizing, neuromuscular relaxant that is sold in the Colombian market as a generic drug and as an innovative drug; reason why it is necessary to make the clinical comparison that allows selecting the best alternative.
Objective: To compare the pharmacodynamic profile of generic rocuronium with its innovative homologue in patients undergoing endotracheal intubation.
Methods: Descriptive, prospective study for comparing the time of relaxation, maximum block and action duration of generic and innovative rocuronium by means of monitoring the muscular conduction with accelerometry in the four-train variant (TOF) ratio T4 / T1 in class I and II patients according to the American Society of Anesthesiologists .The patients were randomly distributed in two groups of 45. The quality in the intubation was compared using the modified Damual Metha scale.
Results: The optimal intubation time for generic rocuronium was 100 ± 2.8 sec and 83 ± 2.88 sec for the innovator (p <0.001).There was no statistically significant difference in the quality of intubation; on the other hand, the time to reach the maximum block with the generic was 110 ± 5 sec, and 103 ± 3.23 sec with the innovator (without significant difference).The times of action duration for the generic were 99.7 ± 1.65 min, and 83.67 ± 1.17 min for the innovator with p <0.001.
Conclusion: When comparing the pharmacodynamic profile of both alternatives, no significant differences were found in them or in maximal blocking time. The innovative option presented shorter latency time than the generic one, whereas in the duration of the action the generic had a longer blocking time.


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Rev Cubana Farm. 2019;52