Surgical Pleth Index - Relevance in Small Children. A Randomised Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surgical Pleth Index (SPI) at the time of start of surgery
研究概览
简要总结
Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption. It has not been tested on small children. The aim of this study is to measure, whether there is a difference in nosiception measured by SPI in a group receiving local anesthetics prior to operation compared to group receiving plasebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 0-2 years
- •Elective surgery planned for inguinal hernia, or testicle retention
- •Written informed consent from parent received
- •ASA I-III
排除标准
- •Exstrasystolias, known cardiac problem, medication affecting rhytm, allergy to drugs used
研究组 & 干预措施
Treatment
Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.
干预措施: Levobupivacaine (Drug)
Treatment
Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.
干预措施: Saline (Drug)
Control group
Patients receive a plasebo saline injetion at the site of ileoinguinal block prior to surgery and an injectio with local anesthetics after surgery. The treatment group is blinded for caregiver.
干预措施: Levobupivacaine (Drug)
Control group
Patients receive a plasebo saline injetion at the site of ileoinguinal block prior to surgery and an injectio with local anesthetics after surgery. The treatment group is blinded for caregiver.
干预措施: Saline (Drug)
结局指标
主要结局
Surgical Pleth Index (SPI) at the time of start of surgery
时间窗: intraoperative
次要结局
未报告次要终点