Clinical trial NCT06711679: Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia
Official title: Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia in Children of Different Ages
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Pediatric ALL
Keywords: Caudal anesthesia
Children
Thermal imaging
Intraoperative MRI
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: Wuhan Children's Hospital
First posted: 2024-12-02
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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;

Primary outcomes:
measure: Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.
timeFrame: 30 minutes
measure: The blockade level after caudal anesthesia with varying doses
timeFrame: 60 minutes
measure: The minimum effective concentration of ropivacaine among pediatric patients of different age groups
timeFrame: 2 days
Secondary outcomes:
measure: Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier
timeFrame: 60 minutes
measure: Effects of different volumes and concentrations of ropivacaine on heart rate
timeFrame: 2 days
measure: Effects of different volumes and concentrations of ropivacaine on blood pressure
timeFrame: 2 days
measure: Effects of different volumes and concentrations of ropivacaine on oxygenation
timeFrame: 2 days
measure: To evaluate the relaxation degree of anal sphincter after sacral anesthesia
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Yilin Zhao, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: