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Therapeutic Advances in Drug Safety 2019Sugammadex is used for the reversal of neuromuscular blockade caused by rocuronium bromide and vecuronium bromide. As part of the post licensing phase of drug...
INTRODUCTION
Sugammadex is used for the reversal of neuromuscular blockade caused by rocuronium bromide and vecuronium bromide. As part of the post licensing phase of drug development, adverse events related to the use of sugammadex are still being uncovered and being reported. The potential association between sugammadex and adverse events bronchospasm and coronary arteriospasm using a retrospective pharmacovigilance signal analysis was carried out.
METHODS
Food and Drug Administration's Adverse Event Reporting System database was used to run disproportionality analyses to investigate the potential association of sugammadex with bronchospasm or coronary arteriospasm. In this analysis we report the adverse event signal using frequentist methods of Relative reporting ratio (RRR), proportional reporting ratio (PRR), reporting odds ratio (ROR) and the Bayesian based Information Component metric.
RESULTS
A statistically significant disproportionality signal is found between sugammadex and bronchospasm ( = 44; chi-squared = 2993.87; PRR = 71.95 [95% CI: 54.00-95.85]) and sugammadex and coronary arteriospasm ( = 6; chi-squared = 209.39; PRR = 43.82 [95% CI: 19.73-97.33]) as per Evans criteria. Both statistically significant disproportionality signals persisted when stratified by gender. Based upon dynamic cumulative PRR graph, the PRR value has steadily increased and the 95% CI narrowed since December 2012.
CONCLUSION
The results of the pharmacovigilance analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex. The results of the pharmacovigilance signal analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex.
PubMed: 31452867
DOI: 10.1177/2042098619869077 -
Medicinski Glasnik : Official... Feb 2020Aim To compare the quality of the conditions for endotracheal intubation and muscle relaxation between rocuronium bromide and vecuronium bromide using the ''timing... (Randomized Controlled Trial)
Randomized Controlled Trial
Aim To compare the quality of the conditions for endotracheal intubation and muscle relaxation between rocuronium bromide and vecuronium bromide using the ''timing principle'' method for induction in anaesthesia. The "timing principle" includes the administration of muscle relaxants before the hypnotic agent during induction in anaesthesia. Method Sixty patients who had undergone elective surgery were randomly allocated into two equal groups using muscle relaxants: rocuronium (group R) and vecuronium (group V). The intubation conditions were assessed using Cooper's scoring system, based on jaw relaxation, vocal cords position and response to intubation. The quality of muscle relaxation was evaluated by recording the time of clinical weakness, a count of ''train of four'' (TOF) twitches at intubation, the time of loss TOF response and duration of direct laryngoscopy. Results The intubation conditions were excellent in 100% of patients in the group R versus excellent in 80% and good in 20% of patients in the group V (p<0.05). The time of clinical weakness was statistically significantly shorter in the group R than in the group V (p<0.000). The time of loss of TOF response was statistically significantly shorter in the group R (p<0.000). The absence of TOF twitches (the level of muscle relaxation of 100%) at intubation recorded in 25 (83.3%) patients in the group R versus five (16.7%) patients in the group V (p<0.000). Duration of direct laryngoscopy did not significantly differ between the groups. Conclusion Rocuronium bromide provides better intubation conditions and greater quality of muscle relaxation than vecuronium bromide using ''timing principle'' technique.
Topics: Androstanols; Humans; Intubation, Intratracheal; Muscle Relaxation; Neuromuscular Nondepolarizing Agents; Rocuronium; Time Factors; Vecuronium Bromide
PubMed: 31402637
DOI: 10.17392/1045-20