Lower abdominal surgery and urogenital surgery are frequently performed surgeries in the
pediatric patient population aged 5-12 years. Therefore, pain, agitation, nausea and
vomiting occurring in the early postoperative period and afterwards are important
problems for pediatric patients. The incidence of agitation, which is a postoperative
behavioral disorder due to the use of sevoflurane and desflurane, varies between 2 and
80%, depending on the scoring system and anesthesia technique. It is more common in
preschool children (3-5 years). Agitation despite spontaneous resolution; It is still
considered a potentially serious complication due to the risks of self-harm and the
stress it causes in the family. It can also cause pain and bleeding, prolonging the
recovery period (1). Therefore, it is a problem that should be avoided.
Neostigmine is the most commonly used agent for reversing neuromuscular blockade (NMB)
(2). Cholinesterase inhibitor agents used in decurarization have serious side effects,
especially because they stimulate the muscarinic system as well as nicotinic receptors
(3). These are hypersalivation, bradycardia, bronchoconstriction, nausea and vomiting,
and abdominal cramps (4).
Sugammadex is a cyclodextrin group drug, which is an aminosteroid neuromuscular blocking
agent, has a selective effect on rocuronium and vecuronium and mechanically binds these
molecules, providing rapid excretion and decurarization. Recurarization and muscarinic
side effects are not expected in this type of decurarization(5). When acetylcholine
esterase inhibitors are used to reverse neuromuscular block, they can cause postoperative
residual curarization (PORC)(6).
Postoperative nausea and vomiting (PONV) is a common complication in the pediatric
population. The incidence in children varies between 33.2% and 82% depending on the risk
factors of the patient. This rate is twice that of adults. PONV typically describes
nausea, vomiting, or retching. It may start in the recovery unit and continue for 24
hours. PONV causes dehydration, electrolyte disturbances, longer stay in the recovery
unit, A< it causes delays and ultimately a significant financial burden(7). Therefore, it
is a complication that should be avoided as much as possible.
Pain is the most important risk factor in the development of agitation. In order to
reduce all these complications, we hypothesized that sugammadex was superior to
neostigmine + atropine in reducing side effects compared to decurarization.In this study,
it was aimed to compare the use of sugammadex instead of neostigmine + atropine in the
reversal of NMB in children undergoing lower abdominal surgery or urogenital surgery, and
to compare the rates of postoperative agitation, nausea and vomiting using the FLACC
scale, PAED scale and ICC parameters.After the approval of the local ethics committee and
written consent from the family, patients who underwent ASA 1, 5-12 years old lower
abdomen surgery or urogenital surgery in Pendik Training and Research Hospital will be
included in the study.
The patients included in the study will be those who were maintained with routine 2-3%
sevoflurane inhalation anesthetic and 0.2mcg/kg/min remifentanil intravenous anesthetic,
and decurarized with 0.5-1 mg/kg rocuronium. No drugs other than those administered by
the responsible Anesthesiologist during the operation will be administered.
The patients included in the study will be divided into 2 groups according to the agent
used in decurarization. There is no condition for the number of patients in the group to
be equal. Group N; neostigmine+atropine, GROUP S; This will be the group of patients
decurarized with sugammadex.
0-45 days after patients are extubated. And at the 2nd hour, FLACC Scale (Pain Diagnostic
Scale), PAED (Pediatric Anesthesia Recovery Delirium) Scale assessment methods will be
compared in terms of pain and agitation. Nausea and vomiting will be noted as SPSS 22.0
program will be used in statistical analysis. Mean, standard deviation, median lowest,
highest, frequency and ratio values will be used in the descriptive statistics of the
data. The distribution of variables will be measured with the Kolmogorov-Smirnov test.
Independent sample t-test and mann-whitney u-test will be used in the analysis of
quantitative independent data. Paired sample t-test will be used in the analysis of
dependent quantitative data. The MC Nemar test will be used in the analysis of dependent
qualitative data. Repeated Measure Anova will be used in the analysis of repeated
measurements. The fischer test will be used when the conditions for the -square test and
chi-square test in the analysis of qualitative independent data are not met.
Power analysis was performed using the G*Power (v3.1.7) program to determine the number
of samples. The power of the study is expressed as 1-β (β = probability of Type II error)
and in general studies should have 80% power. According to Cohen's effect size
coefficients; According to the calculation made by assuming that the evaluations to be
made between two independent groups will have a medium effect size (d=0.50), there must
be at least 65 people in the groups to achieve 80% power at the α=0.05 level.