Comparison of Sugammadex and Neostigmine in Terms of Time to Extubation in Pediatrics

Abstract

ÖzAmaç: Sugammadeks rezidüel nöromüsküler bloğun kısa sürede tam olarak geri dönüşünü sağlayan siklodekstrin grubu bir ilaçtır. Bu çalışmada sugammadeks ve neostigminin dörtlü uyarı (Train of Four -TOF) 0,9 oranına ulaşma zamanı ve ekstübasyon süreleri (TE) değerlendirildi.Yöntemler: Alt üriner sistem veya inguinal herni cerrahisi geçiren, akciğer hastalığı, nöromüsküler hastalığı olmayan 37 hasta, iki gruba ayrılarak çalışmaya dahil edildi. Hastalar cerrahi operasyon sonunda nöromüsküler monitorizasyon yapılarak ekstübe edildi. Grup neostigmin (grup N): Cerrahi operasyon bitiminde TOF 2 olduğunda, intravenöz 0,05 mg/kg neostigmin uygulandı. Grup sugammadeks (grup S): Cerrahi operasyon bitiminde TOF 2 olduğunda, intravenöz 2 mg/kg sugammadeks uygulandı, TOF ≥0,9 ulaşma süresi (T0,9) ve antagonist enjeksiyonunda ekstübasyona kadar geçen süre kaydedildi. Parametreler istatistiksel olarak değerlendirildi. Bulgular:Grup N'deki olgularda TE 6,06±2,47 dakika, grup S'deki olgularda TE 4,30±2,48 dakika olarak saptandı (p<0,041).Sonuç: Sugammadeksin, neostigmine göre daha kısa sürede nöromüsküler bloğu ortadan kaldırdığı saptandı. Ölçüm zamanlarının hiçbirinde hemodinamik bakımdan ve komplikasyonlar açısından ciddi bir değişiklik saptanmadı. Fakat çocuklarda ilacın güvenilirliği ve yan etkilerinin değerlendirilmesi açısından sınırlı sayıda çalışma mevcuttur ve ilacın klinik uygulamasındaki güvenilirliği için daha çok çalışmaya ihtiyaç vardır. Anahtar Sözcükler: Sugammadeks, neostigmin, nöromüsküler blok, pediatrikAim: Sugammadex is a cyclodextrin compound which provides complete recovery of residual neuromuscular blockade. In this study, we compared sugammadex and neostigmine in terms of time to achieve a train-of-four (TOF) ratio of 0.9 and extubation time (TE). Methods:Thirty-seven patients, without lung disease and neuromuscular disease undergoing lower urinary tract surgery and inguinal hernia, were included in the study. Noninvasive arterial pressure, heart rate, pulse oximetry, and TOF-watch SX values were monitored during the surgery and, these parameters were recorded. After the surgery was completed, the patients were randomized into two groups: patients received either group neostigmine (group N) 0.05 mcg/kg and group sugammadex (group S) 2 mg/kg at reappearance of TOF ratio T2. Time to recovery to the TOF ratio of 0.9 (T0.9) and TE were compared between sugammadex and neostigmine Results:TE was found to be statistically longer in group N (6.06±2.47 minute) than in group S (4.30±2.48 minute) (p<0.041). Conclusion:We observed that sugammadex was more rapidly and effectively reversed the neuromuscular blockade compared to neostigmine. There were no serious adverse effects and significant hemodynamic changes in any measurement time. However, there is a limited number of studies on the safety and side effects of sugammadex in pediatric patients and additional data are needed to establish the safety in clinical practice.

The efficacy and safety of sugammadex for reversing postoperative residual neuromuscular blockade in pediatric patients: A systematic review

“…In one study 26 reversal agents were administered at different times between the sugammadex group (PTC < 2–3) and the control group (PTC > 2–3), which we believe may have influenced the primary outcome. We believe that one trial 23 had a low risk of bias because all of the study criteria were assessed as low risk, whereas three trials 25, 26, 28, 30, 31 had high risks, and the risks of other studies 24, 27, 29, 32 were unclear. Assessments of risk of bias are summarized in Fig.…”

“…Six studies 24–27, 29, 32 were unclear about their allocation concealment. Four studies 24, 25, 29, 31 did not report whether the patients and the assessors were blinded during outcome assessments. In the study conducted by El sayed 30 , the assessors were not blinded to the allocation of groups, which may have affected the results of the study; therefore, we evaluated the study as ‘high risk’.…”

“…However, in one study 26 reversal agents were administered at different times between the sugammadex group (PTC < 2–3) and the control group (PTC > 2–3). Inhaled anesthesia was used in six studies 24 , 27 – 31 and TIVA was used in one study 23 , while two studies 25 , 26 , 32 did not report the maintenance of the anesthesia technique. All studies reported the time from the reversal of the neuromuscular blockade to train-of-four ratio (TOFr) > 0.9 as the primary outcome.…”

“…The reason for high heterogeneity in the primary outcome data may be related to the fact that volatile anesthetics, such as sevoflurane or isoflurane, can enhance the effect of neuromuscular blockade agents, thus affecting the reversal of rocuronium-induced neuromuscular paralysis. Six studies 24, 27–31 used various concentrations of sevoflurane, isoflurane or N 2 O during operation, whereas three studies 25, 26, 32 did not report whether volatile anesthetics were used during operation. Another limitation of this meta-analysis is that most of the included studies 24–32 were determined to have unclear or high risk of bias, and the qualities of the primary outcome and most secondary outcomes were assessed as having low risk or very low risk.…”

Sugammadex: Applications in Pediatric Critical Care

“…Several other prospective studies have compared reversal of neuromuscular blockade using sugammadex with the acetylcholinesterase inhibitor, neostigmine (►Table 1). [27][28][29][30][31] These five prospective trials involving a total of 287 pediatric patients have demonstrated various clinical advantages of sugammadex over neostigmine including a more rapid return of the TOF ratio to ! 90% and a shorter time to tracheal extubation with sugammadex than with neostigmine.…”