|Year : 2017 | Volume
| Issue : 3 | Page : 143-148
Efficacy of sugammadex compared with neostigmine for reversal of rocuronium-induced neuromuscular blockade and deep extubation in outpatient surgeries for asthmatic pediatric patients
Eslam N Nada
Anaesthesia and Intensive Care Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt
|Date of Submission||03-Dec-2016|
|Date of Acceptance||23-Mar-2017|
|Date of Web Publication||5-Jul-2017|
Eslam N Nada
Flat 702, El Hedaya Tower 1, Moahada Street, El Sharkia, Zagazig 44519
Source of Support: None, Conflict of Interest: None
Bronchial asthma in children is considered a challenge for the anesthesiologist because of the perioperative adverse effects, especially the risk for bronchospasm either during induction or more commonly during recovery and extubation. Therefore, the goal should be to minimize this risk by avoiding any triggering stimulus and deep extubation with adequate recovery from the neuromuscular blocker to have full control of pharyngeal and respiratory muscles. The aim of this study was to compare the efficacy of sugammadex with neostigmine on reversing rocuronium-induced neuromuscular blockade (NMB) in asthmatic pediatric patients undergoing outpatient surgical procedures.
Patients and methods
This prospective randomized study was conducted on 60 patients, aged 3–12 years, with history of bronchial asthma, and scheduled for outpatient lower abdominal or urogenital surgeries. NMB was achieved by administration of rocuronium 0.6 mg/kg and monitorized subjectively with train-of-four mode of peripheral nerve stimulator. Patients were randomly allocated into two groups by using the sealed-envelope method: group N (n=30), which received 0.04 mg/kg neostigmine, and group S (n=30), which received 2 mg/kg sugammadex for reversal of rocuronium-induced NMB. Duration of surgery, time from injection of the reversal agent to the time of extubation (time to extubation), total doses of rocuronium, and time from extubation to recovery were recorded. Any complications such as hemodynamic abnormalities, retching, vomiting, bucking, bronchospasm, laryngospasm, coughing, need for reintubation, or any other complications were recorded.
There was no significant difference between the two groups as regards age, sex, weight, duration of surgery, and total doses of rocuronium. On the other hand, there was statistically significant difference between the two groups regarding time of NMB reversal to time of extubation: 13.43±4.92 min in the neostigmine group versus 1.84±0.66 min in the sugammadex group (P<0.0001). Moreover, there was statistically significant difference between the two groups regarding time from extubation till time of recovery: 21±5.72 min in group N versus 25.57±5.72 min in group S (P=0.019). Regarding complications, need for succinylcholine, and need for reintubation, although their incidence was higher in the neostigmine group, there was no statistically significant difference between the two groups.
It was concluded that reversal of rocuronium-induced NMB by using sugammadex was more rapid and safer when compared with neostigmine in asthmatic pediatric patients undergoing outpatient lower abdominal or urogenital surgeries.
Keywords: asthma, bronchospasm, neostigmine, pediatric, rocuronium, sugammadex
|How to cite this article:|
Nada EN. Efficacy of sugammadex compared with neostigmine for reversal of rocuronium-induced neuromuscular blockade and deep extubation in outpatient surgeries for asthmatic pediatric patients. Res Opin Anesth Intensive Care 2017;4:143-8
|How to cite this URL:|
Nada EN. Efficacy of sugammadex compared with neostigmine for reversal of rocuronium-induced neuromuscular blockade and deep extubation in outpatient surgeries for asthmatic pediatric patients. Res Opin Anesth Intensive Care [serial online] 2017 [cited 2017 Nov 24];4:143-8. Available from: http://www.roaic.eg.net/text.asp?2017/4/3/143/209664
| Introduction|| |
Bronchial asthma is considered one of the most common chronic diseases in children . Together with respiratory infection, they have significant importance in the perioperative period for the anesthesiologists, especially at induction and emergence from general anesthesia and extubation because of the increased risk for bronchospasm, which is considered a life-threatening complication .
Deep extubation technique is preferred in asthmatic patients to reduce the risk for bronchospasm, but before attempting deep extubation, there should be adequate spontaneous respiration without excessive stimulation during suctioning of secretions ,
Rocuronium can be used safely in asthmatic patients because it is one of the of non-histamine-releasing muscle relaxants 
On the other hand, the use of neostigmine can cause bronchospasm because of its muscarinic effect, but practically, this is not an issue when given together along with atropine or glycopyrrolate. Other side effects due to stimulation of muscarinic receptors include bradycardia, prolonged QT interval, and increased salivation. Unfortunately, the available data for the use of sugammadex in children especially below 2 years old are insufficient ,.
Postoperative residual curarization (PORC) can occur even in asymptomatic patients due residual block of up to 60–70% of nicotinic receptors; this can lead to many complications like delayed recovery, hypoxia, metabolic disorders, and even death ,.
Nowadays, with the use of sugammadex as selective reversal for rocuronium and vecuronium blockade, PORC and muscarinic side effects are not anticipated .
A modified γ-cyclodextrin, sugammadex (Org 25969) was discovered in 2001 by Bom and colleagues. It is bound to rocuronium in a 1 : 1 ratio, decreasing its plasma concentration to 0 ,. The first application of sugammadex to a human was in 2005 and proved to be safe and effective .
In 2008, the European Medicines Agency approved sugammadex for clinical use. It is licensed worldwide (except in the USA) to reverse any depth of neuromuscular block (NMB) induced by rocuronium or vecuronium in adults and children more than 2 years of age. The trade name for sugammadex is Bridion (100 mg/ml), and it can be obtained in 2 ml (200 mg) and 5 ml (500 mg) vials ,.
For routine reversal of NMB with rocuronium or vecuronium, a dose of 4 mg/kg is recommended if recovery reaches one to two post-tetanic counts, and 2 mg/kg if there is spontaneous recovery on ulnar nerve stimulation by train-of-four (TOF) mode to at least T2. The median time to recovery of the T4/T1 ratio to 0.9 is about 3 min. For immediate reversal of rocuronium-induced blockade, 16 mg/kg of sugammadex is recommended. If this is given 3 min after a bolus of 1.2 mg/kg rocuronium for rapid sequence induction (RSI), the median time to recovery of the T4/T1 ratio to 0.9 is ∼1.5 min ,.
Because of the rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in drug distribution and body volume in children can alter neuromuscular conduction causing prolonged recovery and increased risk for PORC ,.
The pharmacokinetic and pharmacodynamic profile for rocuronium differs not only between children and adults but also between infants and children . The duration of rocuronium has been found to be prolonged in infants compared with children, with greater potency in infants and less in children, compared with adults ,.
Based on Plaud et al. , sugammadex (2 mg/kg) can be recommended for routine reversal of rocuronium-induced NMB at reappearance of T2 on TOF in children aged more than 2 years. No recommendation for infants was made because of the low number of participants in this study. Immediate reversal (16 mg/kg of sugammadex) in children or adolescents has not been studied and is not currently recommended.
The aim of this study was to compare the efficacy of sugammadex versus neostigmine on reversing rocuronium-induced NMB in asthmatic pediatric patients undergoing outpatient surgical procedures.
| Patients and methods|| |
This prospective, randomized study was performed in Zagazig University Hospital. After obtaining approval of the hospital’s ethics committee and an written informed consent from the parents or guardians of the children, a total of 60 children, belonging to the American Society of Anesthesiologists physical status II with history of bronchial asthma, aged from 3 to 12 years old, and who were scheduled for elective outpatient lower abdominal or urogenital surgeries, were included in this study. These patients were divided randomly by using closed envelopes into two groups: the neostigmine group (group N) (n=30) and the sugammadex group (group S) (n=30).
Exclusion criteria included history of allergy to any of the used drugs, musculoskeletal diseases, cardiac diseases, liver and kidney diseases, and expected difficult airway management.
Standard monitoring was applied for all patients; ECG, noninvasive blood pressure, pulse oximetry, and capnograph for end-tidal CO2 monitoring (after intubation).
The TOF twitches were applied to the ulnar nerve by a nerve stimulator with monitoring of adductor pollicis muscle (thumb muscle).
Venous catheter was inserted on the arm opposite to the side of the nerve stimulator.
General anesthesia was administered in both groups with 3 mg/kg propofol, 1 mcg/kg fentanyl, and 0.6 mg/kg rocuronium, and then the endotracheal tube was inserted and capnograph was attached for each patient. Tidal volume was calculated as 7 ml/kg.
Anesthesia was maintained with 2% isoflurane and 100% oxygen.
Top-up doses of rocuronium 0.2 mg/kg were given based on TOF monitoring. The total doses of rocuronium were recorded.
At the end of surgery, TOF monitoring was continued without discontinuation of isoflurane.
With reappearance of T2, patients in group N (n=30) received 0.04 mg/kg neostigmine and 0.4 mg atropine/1 mg neostigmine for reversal of rocuronium-induced NMB, whereas patients in group S (n=30) received 2 mg/kg sugammadex (Bridion; Merck, USA).
After reversal of NMB, suction of secretions was carried out gently and the patients were monitored clinically and with monitoring exhaled tidal volume for adequate tidal volume (≥50% of normal) together with TOF monitoring till reappearance of T4 with fade no longer detected visually. Then isoflurane was discontinued and patients were extubated.
Duration of surgery, time from injection of neostigmine or sugammadex to the time of extubation (time to extubation), and time from extubation to recovery (crying, voluntary movements, or spontaneous eye opening) were recorded.
Any complications such as hemodynamic abnormalities, retching, vomiting, bucking, bronchospasm, laryngospasm, coughing, need for reintubation, or any other complications were recorded.
Laryngospasm was treated by jaw thrust and positive pressure ventilation through a face mask or by succinylcholine and reintubation if needed, whereas bronchospasm was treated by using hydrocortisone 3 mg/kg, theophylline 5 mg/kg, and a nebulizer setting with salbutamol (0.1 mg/kg/dose) and adrenaline (0.1 ml/kg/dose in one in 10 000 solution) or with a muscle relaxant and reintubation with mechanical ventilation in resistant cases.
A sample size of 50 patients (25 patients in each group) was needed to achieve 80% power to detect 50% difference in time to extubation after reversal of NMB. Sixty patients (30 patients in each group) were included to account for any dropouts.
The collected data were analyzed by using the statistical package for the social sciences (version 16) (SPSS Inc., 233 South Wacker Drive, 11th Floor, Chicago, IL, USA), using Student’s t-test and Fisher’s exact test. Data were expressed as mean±SD or as number and percentage of the total number of patients. P-value less than 0.05 was considered statistically significant.
| Results|| |
All enrolled patients completed the study and were included in the analysis.
There was no significant difference between the two groups as regards age, sex, weight, duration of surgery, and total doses of rocuronium. On the other hand, there was statistically significant difference between the two groups regarding time of NMB reversal to time of extubation: 13.43±4.92 (4.5–22.5) min in the neostigmine group versus 1.84±0.66 (1–3) min in the sugammadex group (P<0.0001). Moreover, there was statistically significant difference between the two groups regarding time from extubation till time of recovery: 21±5.72 (15–30) min in group N versus 25.57±5.72 (18–35) min in group S (P=0.019) ([Table 1]).
|Table 1 Demographic data, duration of surgery, total doses of rocuronium, time from reversal of neuromuscular block to extubation, and time from extubation till recovery|
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Regarding complications, need for succinylcholine, and need for reintubation, although their incidence was higher in the neostigmine group, there was no statistically significant difference between the two groups. Laryngospasm occurred in 12 patients in group N compared with eight patients in group S. On the other hand, cough and bucking occurred in eight patients, of which four developed bronchospasm in the neostigmine group, compared with six patients in the sugammadex group, of which two developed bronchospasm. Five patients needed succinylcholine administration and three of them needed reintubation in group N, whereas two patients in group S needed succinylcholine administration with one patient needing reintubation ([Table 2]).
|Table 2 Complications, need of succinylcholine, and need for reintubation|
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| Discussion|| |
Despite the importance of muscle relaxants in general anesthesia, we cannot ignore their adverse effects that can be fatal in some cases, such as PORC, impaired respiration, impaired laryngeal, and pharyngeal functions, hypoxia and aspiration. Therefore, insuring complete recovery is essential ,,.
Because of larger extracellular fluid and relative immaturity of the neuromuscular junction in children compared with adults, muscle relaxant doses have to be increased in children to obtain the same degree of NMB as in adults; moreover, the children’s diaphragm with its type I fibrins is more susceptible for NMB compared with other muscles. All these factors increase the risk for complications in children ,,.
Bronchial asthma in children is a challenge for the anesthesiologist. Proper preoperative evaluation and optimization is important for a successful outcome. The goal is to minimize the risk for bronchospasm and avoid any triggering stimulus. Bronchospasm is most likely to occur at induction and emergence. Use of non-histamine-releasing muscle relaxants like rocuronium is considered safe in asthmatic children. Besides it has been ascertained that NMB with rocuronium is reversed in a shorter time by sugammadex. Deep extubation technique is preferred to blunt the risk for bucking-induced bronchospasm, but before attempting deep extubation, it is important to ensure efficient reversal of NMB and unobstructed spontaneous breathing ,,.
Reversal by neostigmine will remain incomplete regardless of the dose administered if reversal is attempted at deeper levels of block, because neostigmine will be unable to increase the amount of acetylcholine beyond a ceiling effect and thus cannot return the TOF ratio to the required 0.90 to minimize the risk for symptoms and complications due to postoperative residual paralysis ,.
A study by Illman et al.  reported that there is a potentially unsafe period of recovery defined as the time gap between loss of visual fade of muscle contraction and the return of objective TOF ratio to 0.9. This unsafe period was shorter in the sugammadex group compared with the neostigmine group.
The use of objective neuromuscular monitoring to minimize the incidence of residual paralysis is considered more accurate and reliable compared with tactile or visual evaluation of muscle contraction responses after stimulation by a peripheral nerve stimulator ,.
Nevertheless, the use of tactile or visual evaluation instead of objective monitoring together with diffuse clinical signs of recovery is still widespread in the clinical setting. Moreover, some anesthesiologists do not give reversal when there is no fade in muscular response to nerve stimulation ,.
In the present study, the extubation times were significantly shorter in the sugammadex group compared with the neostigmine group, which was in agreement with the findings of several other studies that also demonstrate that sugammadex is more effective than cholinesterase inhibitors in the reversal of NMB when rocuronium is used as a muscle relaxant ,,,,,.
Khuenl-Brady et al.  compared neostigmine with sugammadex when used to reverse the NMB obtained by rocuronium or vecuronium in adults. In the rocuronium group, the duration from sugammadex or neostigmine administration to reach 0.90 TOF ratio was found to be 1.4 min with sugammadex and 17.6 min with neostigmine.
Jones et al.  found that the time to reach 0.90 TOF ratio was 18 times shorter if sugammadex was used instead of neostigmine for reversal of deep NMB. This means that recovery from profound rocuronium-induced NMB was significantly faster with sugammadex compared with neostigmine, suggesting that sugammadex has a unique ability to rapidly reverse profound rocuronium-induced NMB. On the other hand, a study of Blobner et al.  found that the time needed to reach 0.90 TOF ratio was 0.46 min in the sugammadex group and 1.96 min in the neostigmine group.For choosing the efficient dose of sugammadex, a dose of 2 mg/kg for reversal of NMB was used in this study, which was supported by a study by Sorgenfrei et al.  who compared different doses of sugammadex (0.5, 1, 2, 3, 4 mg/kg) with a placebo administration and found that with every dose of sugammadex the time to reach 0.90 TOF ratio shortened; they also observed that the time to reach 0.90 TOF ratio was significantly shorter with sugammadex doses more than or equal to 2 mg/kg.
Other similar studies showed the same results that sugammadex doses of at least 2 mg/kg are efficient in reversal of NMB ,.
Regarding the incidence of postanesthetic respiratory adverse events, they were comparable between the sugammadex group and the neostigmine group, although higher in the neostigmine group. These results were in agreement with the results of Won et al.  and Plaud et al.  (for pediatric patients); Ledowski et al.  and Ledowski et al.  (for elderly patients); and with Tiberiu et al.  (after laparoscopic sleeve gastrectomy). The limitation of this study was the use of a subjective method (visually) rather than objective means in the detection of TOF response, which was due to the unavailability of the objective means in our hospital.
| Conclusion|| |
In this study it was concluded that the administration of sugammadex for reversal of rocuronium-induced NMB was more rapid and safer when compared with neostigmine in asthmatic pediatric patients undergoing outpatient lower abdominal or urogenital surgeries.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]