A Phase 4 interventional study of Low-dose ropivacaine and Medium-dose of ropivacaine in Pediatric ALL, sponsored by Yilin Zhao. Enrolling by invitation at 1 site in China. Open to participants aged 1 Day to 7 Years. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Yilin Zhao · Phase 4, Interventional, and Treatment
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:
Participants will:
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
Yilin Zhao is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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;
From birth to 28 days
Drug: Low-dose ropivacaine · Drug: Medium-dose of ropivacaine · Drug: High-dose ropivacaine
1 month to 1 year
Drug: Low-dose ropivacaine · Drug: Medium-dose of ropivacaine · Drug: High-dose ropivacaine
1-3 years
Drug: Low-dose ropivacaine · Drug: Medium-dose of ropivacaine · Drug: High-dose ropivacaine
3-7 years
Drug: Low-dose ropivacaine · Drug: Medium-dose of ropivacaine · Drug: High-dose ropivacaine
0.5 ml/Kg ropivacaine
Also known as: MRI scan
1ml/Kg ropivacaine
Also known as: MRI scan
1.5 ml/Kg ropivacaine
Also known as: MRI scan
Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.
MRI scan will be performed before and after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection,
Time frame: 30 minutes
The blockade level after caudal anesthesia with varying doses
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.
Time frame: 60 minutes
The minimum effective concentration of ropivacaine among pediatric patients of different age groups
The fixed capacity requires the minimum effective concentration by changing the concentration
Time frame: 2 days
Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier
Optic Nerve Sheath Diameter (ONSD) and blood brain barrier will be meseared before and after injection, and after sugery operation
Time frame: 60 minutes
Effects of different volumes and concentrations of ropivacaine on heart rate
Effects on heart rate after different volumes and concentrations of ropivacaine injection
Time frame: 2 days
Effects of different volumes and concentrations of ropivacaine on blood pressure
Effects on blood pressure after different volumes and concentrations of ropivacaine injection
Time frame: 2 days
Effects of different volumes and concentrations of ropivacaine on oxygenation
Effects on oxygenation after different volumes and concentrations of ropivacaine injection
Time frame: 2 days
To evaluate the relaxation degree of anal sphincter after sacral anesthesia
Measure the pressure changes of the anal sphincter after caudal anesthesia using a pressure sensor
Time frame: 30 minutes
Plan to share: No
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Yilin Zhao