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临床试验/NCT05618236
NCT05618236已完成不适用

Comparison of Sugammadex and Neostigmine in Terms of Awakening, Pain, Agitation, Nausea and Vomiting in Pediatric Patients''

Marmara University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
postoperative delirium

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • After the approval of the local ethics committee and written consent from the family ASA 1 5-12 years old

排除标准

  • history of allergy or anaphylaxis to one of the drugs used children with autism children with auditory problems family without consent

研究组 & 干预措施

neostigmin+atropin

This will be the group of patients decurarized with neostigmine+atropine,

干预措施: Group N; neostigmine+atropine (Drug)

sugammadeks

This will be the group of patients decurarized with sugammadex.

干预措施: GROUP S; decurarized with sugammadex. (Drug)

结局指标

主要结局

postoperative delirium

时间窗: postoperatif first 2 hours.

after patients are extubated. Evaluation Pediatric Anesthesia Recovery Delirium Scale at 2nd Hour

次要结局

  • postoperative pain(postoperatif first 2 hours.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meliha Orhon

assistant professor

Marmara University

研究点 (1)

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