Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia

Официальное название

Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia in Children of Different Ages

Обзор

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

Подробное описание

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

Вмешательства

• Препарат Low-dose ropivacaine
  0.5 ml/Kg ropivacaine
• Препарат Medium-dose of ropivacaine
  1ml/Kg ropivacaine
• Препарат High-dose ropivacaine
  1.5 ml/Kg ropivacaine

Первичные конечные точки

• Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine. [Срок оценки: 30 minutes]
• The blockade level after caudal anesthesia with varying doses [Срок оценки: 60 minutes]
• The minimum effective concentration of ropivacaine among pediatric patients of different age groups [Срок оценки: 2 days]

Вторичные конечные точки (5)

• Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier [Срок оценки: 60 minutes]
• Effects of different volumes and concentrations of ropivacaine on heart rate [Срок оценки: 2 days]
• Effects of different volumes and concentrations of ropivacaine on blood pressure [Срок оценки: 2 days]
• Effects of different volumes and concentrations of ropivacaine on oxygenation [Срок оценки: 2 days]
• To evaluate the relaxation degree of anal sphincter after sacral anesthesia [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

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.

Критерии исключения

Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT06711679 · 2024S006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗