Pediatric ALL
Conditions
Keywords
Caudal anesthesia, Children, Thermal imaging, Intraoperative MRI
Brief summary
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
Detailed description
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
Interventions
DRUGLow-dose ropivacaine
0.5 ml/Kg ropivacaine
DRUGMedium-dose of ropivacaine
1ml/Kg ropivacaine
DRUGHigh-dose ropivacaine
1.5 ml/Kg ropivacaine
Sponsors
Henan Provincial People's Hospital
Wuhan Children's Hospital
Yilin Zhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine. | 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 | 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 | 2 days | The fixed capacity requires the minimum effective concentration by changing the concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of different volumes and concentrations of ropivacaine on oxygenation | 2 days | Effects on oxygenation after different volumes and concentrations of ropivacaine injection |
| Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier | 60 minutes | Optic Nerve Sheath Diameter (ONSD) and blood brain barrier will be meseared before and after injection, and after sugery operation |
| To evaluate the relaxation degree of anal sphincter after sacral anesthesia | 30 minutes | Measure the pressure changes of the anal sphincter after caudal anesthesia using a pressure sensor |
| Effects of different volumes and concentrations of ropivacaine on heart rate | 2 days | Effects on heart rate after different volumes and concentrations of ropivacaine injection |
| Effects of different volumes and concentrations of ropivacaine on blood pressure | 2 days | Effects on blood pressure after different volumes and concentrations of ropivacaine injection |
Countries
China
Outcome results
None listed