NCT06679569招募中不适用
Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- ANIm (Analgesia Nociception Index) Value
研究概览
简要总结
This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia.
- •American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
排除标准
- •Patients undergoing emergency surgery.
- •Patients with chronic pain or currently taking analgesics for chronic pain.
- •Known hypersensitivity to general anesthetic agents or analgesics.
- •Patients with underlying cardiovascular disease.
- •Patients with neuromuscular disorders.
- •Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
研究组 & 干预措施
moderate neuromuscular blockade
Active Comparator
干预措施: rocuronium 0.2 mg/kg/hr continuous infusion (Drug)
deep neuromuscular blockade
Experimental
干预措施: rocuronium 0.6 mg/kg/hr continuous infusion (Drug)
结局指标
主要结局
ANIm (Analgesia Nociception Index) Value
时间窗: 30 minutes after arrival in the recovery room
次要结局
- FLACC Pain Scale(30 minutes after arrival in the recovery room)
- Pediatric Anesthesia Emergence Delirium Scale(30 minutes after arrival in the recovery room)
- Time to Extubation(From end of surgery to extubation (in minutes, assessed up to 1 hour))
- Recovery Room Length of Stay(Duration of stay in the recovery room (in minutes, assessed up to 2 hours))
- Remifentanil Consumption During Anesthesia(During surgery ( assessed up to 5 hours))
- Change in Pain Score (FLACC Pain Scale)(Every 6 hours up to 24 hours post-surgery)
- Maximum Pain Score (FLACC Pain Scale) within 24 Hours(Within 24 hours post-surgery)
- Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight(Within 24 hours post-surgery)
- Peak Intraabdominal Pressure During Surgery(During surgery (assessed up to 5 hours))
- Peak Inspiratory Pressure During Surgery(During surgery (assessed up to 5 hours))
- Leiden Surgical Rating Scale(During surgery (assessed up to 5 hours))
- Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)(During recovery room stay (assessed up to 2 hours))
- Any complications Occurring Before Discharge(Up to discharge (assessed up to 1 month))
研究者
Ji-Hyun Lee
Professor
Seoul National University Hospital
研究点 (1)
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