Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- remifentanil total dose in microgram
研究概览
简要总结
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients - an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry - to figure out whether pupillometry monitoring may reduce remifentanil consumption during anesthesia while providing sufficient analgesia for surgical noxious stimuli.
详细描述
comparison of total used opioid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to.
Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as "A" or "B" until data analysis of the last participant is done.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective surgery with estimated time of operation 2 hours or longer, under general anesthesia
- •American Society of Anesthesiologists physical status classification (ASA class) I - II
- •Patient and his/her parents are willing to participate after explanation of the purpose, materials, methods, possible risks and benefits of the research
排除标准
- •History of hypersensitivity/allergic reaction to the drugs which are used in general anesthesia
- •Preoperative use of analgesics, antipsychotics and/or antiepileptics
- •Mental retardation
- •Medications related to hindrance of autonomic nerve system activity, e. g., beta blockers
- •Underlying ophthalmic diseases
结局指标
主要结局
remifentanil total dose in microgram
时间窗: from beginning of anesthesia to the end of the anesthesia
Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
FLACC score
时间窗: Arrival at the post-anesthesia care unit
FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
Adjusted analgesic dose after anesthesia
时间窗: 24 hours after the end of anesthesia
Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia
次要结局
- Emergence time(Intraoperative)
- Incidence of rescue therapy(Intraoperative)
研究者
Hee-Soo Kim
princial investigator
Seoul National University Hospital