Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia in Children of Different Ages
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.
研究概览
简要总结
The goal of this clinical trial is to explore the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. The main questions it aims to answer are:
- The distribution of different volumes of ropivacaine after caudal anesthesia
- The blockade level after caudal anesthesia with varying doses
- The minimum effective concentration of ropivacaine among pediatric patients of different age groups Researchers will inject different doses or concentrations of ropivacaine into the caudal canal to observe the drug's spread range, the level of blockade, and the duration of its effect.
Participants will:
- Undergo magnetic resonance imaging (MRI) examinations before and after caudal anesthesia
- Will be detected the blockade level after caudal anesthesia
详细描述
The activity of CYP1A2 in newborns and infants is lower than in adults, which may result in slower metabolism of ropivacaine. This might necessitate a reduction in the dosage or concentration of ropivacaine to prevent drug accumulation and toxicity. Additionally, since the nervous system in children is still developing, excessively high concentrations of ropivacaine could have adverse effects. Therefore, the lowest effective concentration of ropivacaine should be chosen to minimize the risk of adverse reactions. Generally, the dosage of ropivacaine should be determined based on the patient's age, weight, and the type of surgery. However, there are currently no definitive dosage recommendations, and further research is needed to determine these guidelines.
The goal of this clinical trial is to exploring the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. Using MRI to investigate the distribution of different doses of ropivacaine after caudal anesthesia, and employing infrared imaging technology to detect the blockade level after caudal anesthesia with varying doses.
Participants will receive 0.5ml/Kg, 1ml/Kg and 1.5ml/Kg ropivacaine, then undergo magnetic resonance imaging (MRI) examinations to detect the distribution and optic nerve sheath diameter (ONSD) before and after caudal injection. Also, the blockade level will be detected 15min and 30 min after caudal anesthesia
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
- 1 Day 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≤ 30 kg/m²; lower limbs surgery; lower abdomen surgery; perineal region surgery; Normal liver and kidney function; Normal coagulation function; Hemoglobin > 70 g/L.
排除标准
- •Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;
研究组 & 干预措施
Child Group
3-7 years
干预措施: Low-dose ropivacaine (Drug)
Child Group
3-7 years
干预措施: Medium-dose of ropivacaine (Drug)
Neonatal group
From birth to 28 days
干预措施: Low-dose ropivacaine (Drug)
Neonatal group
From birth to 28 days
干预措施: Medium-dose of ropivacaine (Drug)
Neonatal group
From birth to 28 days
干预措施: High-dose ropivacaine (Drug)
Infant group
1 month to 1 year
干预措施: Low-dose ropivacaine (Drug)
Infant group
1 month to 1 year
干预措施: Medium-dose of ropivacaine (Drug)
Infant group
1 month to 1 year
干预措施: High-dose ropivacaine (Drug)
Toddler Group
1-3 years
干预措施: Low-dose ropivacaine (Drug)
Toddler Group
1-3 years
干预措施: Medium-dose of ropivacaine (Drug)
Toddler Group
1-3 years
干预措施: High-dose ropivacaine (Drug)
Child Group
3-7 years
干预措施: High-dose ropivacaine (Drug)
结局指标
主要结局
Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.
时间窗: 30 minutes
MRI scan will be performed before and after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection,
The blockade level after caudal anesthesia with varying doses
时间窗: 60 minutes
The blockade level will be tested 15 min and 30min after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection. The infrared imaging technology will be employed to test the blockade level.
The minimum effective concentration of ropivacaine among pediatric patients of different age groups
时间窗: 2 days
The fixed capacity requires the minimum effective concentration by changing the concentration
次要结局
- Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier(60 minutes)
- Effects of different volumes and concentrations of ropivacaine on heart rate(2 days)
- Effects of different volumes and concentrations of ropivacaine on blood pressure(2 days)
- Effects of different volumes and concentrations of ropivacaine on oxygenation(2 days)
- To evaluate the relaxation degree of anal sphincter after sacral anesthesia(30 minutes)
研究者
Yilin Zhao
Principal Investigator
Tongji Hospital