The Effect of Methylprednisolone Administration on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- reversal time
研究概览
简要总结
The aim of this study is to thoroughly investigate the interaction between methylprednisolone and sugammadex in the pediatric patient population. Our hypothesis is that methylprednisolone will interact with sugammadex, leading to a prolonged reversal time of rocuronium by sugammadex and, at the same time, a reduction in the effect profile of methylprednisolone.
Approximately 80 volunteers will be included in the study. Patients will not have any additional responsibilities related to this study. There are no risks or benefits to patients associated with this research. The study will begin immediately before the patient's surgery and will end two hours after the operation. Volunteers participating in the study will be randomly assigned to one of two groups: one group will receive methylprednisolone during surgery, and the other group will not. Methylprednisolone is a medication used to prevent postoperative pain, swelling, nausea, and vomiting. If these complaints are detected in patients from either group after surgery, appropriate treatments will be administered to alleviate them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are able to provide informed consent and reliably report symptoms to the research team,
- •Classified as Physical Status 1 and 2 according to the American Society of Anesthesiologists (ASA).
排除标准
- •Patients for whom parental or personal consent could not be obtained
- •ASA Physical Status 3 or higher
- •Known history of allergic reactions to the drugs specified in the protocol
- •Patients requiring emergency surgery
- •Expected difficult airway
- •Preoperative corticosteroid use
- •Presence of respiratory system diseases
- •Presence of neuromuscular diseases
- •Presence of enzymatic or endocrine disorders
- •Presence of liver or kidney failure
- •Presence of cardiovascular diseases
- •Patients with abnormal cognitive or physical development
- •History of treatment with drugs that have a high potential for interaction with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid).
研究组 & 干预措施
Group M
In addition to the routine anesthesia protocol, 1 mg/kg of methylprednisolone will be administered after induction.
干预措施: methylprednisolone (Drug)
Group C
Routine anesthesia will be administered.
干预措施: Saline (NaCl 0,9 %) (placebo) (Other)
结局指标
主要结局
reversal time
时间窗: The study will conclude after the patient has been postoperatively monitored for 2 hours in the recovery unit
The time to reach a TOF ratio of 0.9 after sugammadex administration and the time until extubation will be recorded for all patients.
次要结局
未报告次要终点
研究者
MUSTAFA BÜYÜKCAVLAK
Medical Doctor
Konya City Hospital