Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05618236 |
| Other study ID # |
09.2022.98 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2022 |
| Est. completion date |
April 15, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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 yes/no.
Description:
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.
