Comparison of the Effects of the Interaction of Methylprednisolone and Dexamethasone With Sugammadex on Rocuronium Reversal Time, Postoperative Pain, and Nausea in Pediatric Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection
研究概览
简要总结
This randomized controlled trial aims to compare the interaction of methylprednisolone and dexamethasone with sugammadex in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The primary objective is to evaluate the effect of these corticosteroids on the reversal time of rocuronium-induced neuromuscular block by sugammadex. Secondary outcomes include postoperative pain, nausea and vomiting, extubation time, and adverse events. Eligible participants are children aged 5 to 12 years, ASA I-II, scheduled for elective surgery under general anesthesia. The study is designed as a triple-blind, parallel-group trial with three arms: methylprednisolone, dexamethasone, and placebo.
详细描述
Neuromuscular blocking agents (NMBAs) are widely used in pediatric anesthesia to facilitate tracheal intubation and optimize surgical conditions. However, residual neuromuscular block may increase the risk of postoperative respiratory complications, especially in children who have shorter safe apnea times due to their unique anatomical and physiological characteristics. Sugammadex, a modified γ-cyclodextrin, is a selective reversal agent for aminosteroid NMBAs such as rocuronium. Its mechanism of encapsulating steroidal neuromuscular blocking molecules raises concerns about potential interactions with other steroidal drugs, including perioperatively used corticosteroids.
Corticosteroids are commonly administered in the perioperative period for their antiemetic, analgesic, and anti-inflammatory effects. Dexamethasone is widely accepted for postoperative nausea and vomiting prophylaxis, while methylprednisolone is preferred for its rapid anti-inflammatory effect. Previous studies have suggested that the structural similarity of corticosteroids to rocuronium may interfere with sugammadex binding, but the available evidence is conflicting, and data on methylprednisolone remain limited. In a prior study, methylprednisolone was shown to prolong sugammadex reversal time slightly, but no direct comparison with another corticosteroid was performed.
This randomized controlled trial is designed to compare the effects of methylprednisolone and dexamethasone on sugammadex reversal time in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The study will assess whether methylprednisolone has a stronger interaction with sugammadex compared with dexamethasone, leading to prolonged recovery from rocuronium block. Secondary outcomes will include postoperative pain, nausea and vomiting, extubation time, and adverse events. The results may provide clinically relevant evidence regarding the choice of corticosteroid in pediatric anesthesia when sugammadex is used for neuromuscular block reversal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Children aged 5-12 years
- •American Society of Anesthesiologists (ASA) physical status I-II
排除标准
- •ASA physical status ≥ III
- •Emergency surgery
- •Known allergy or contraindication to neuromuscular blocking agents, sugammadex, or corticosteroids
- •Chronic or recent systemic corticosteroid use (within the last 3 months)
- •Neuromuscular disorders (e.g., muscular dystrophy, myasthenia gravis)
- •Severe hepatic or renal dysfunction
- •Significant respiratory or cardiac disease
- •Anticipated difficult airway or history of difficult intubation
- •Developmental delay or craniofacial anomalies affecting airway management
- •Refusal of consent
研究组 & 干预措施
Methylprednisolone
Patients will receive intravenous methylprednisolone 1 mg/kg at the induction of anesthesia.
干预措施: Methyl Prednisolone (MP) (Drug)
Dexamethasone
Patients will receive intravenous dexamethasone 0.2 mg/kg at the induction of anesthesia
干预措施: Dexamethasone (0.2 mg/kg) (Drug)
Control
Patients will receive 5 ml of intravenous normal saline at the induction of anesthesia
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection
时间窗: From intravenous administration of sugammadex until achievement of normalized TOF ratio ≥ 0.9 (in seconds).
Time from intravenous sugammadex administration to restoration of normalised train-of-four ratio ≥ 0.9, measured by quantitative acceleromyography at the adductor pollicis muscle under standardized monitoring conditions.
次要结局
- Extubation time(From intravenous administration of sugammadex until tracheal extubation (in minutes).)
- Postoperative pain score(At 2 hours after surgery.)
- Postoperative Nausea Severity(At 2 hours after surgery.)
研究者
MUSTAFA BÜYÜKCAVLAK
Specialist in Anesthesiology and Intensive Care, Principal Investigator
Konya City Hospital