A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia in Children Undergoing Elective Infra-Umbilical Surgeries: A Randomized Double-Blinded Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The peak sensory level
研究概览
简要总结
Pediatric anesthesia presents distinctive challenges, particularly concerning appropriate dosage administration of local anesthetics for spinal anesthesia (SA). Spinal anesthesia in infants has been linked to a lower incidence of hypotension, hypoxia, bradycardia, and postoperative apnea in comparison to general anesthesia (GA); ensuring a high level of cardiovascular and respiratory stability.
Additionally, SA has been linked to lower operating room time, post-anesthesia care unit, hospital length of stay, corticosteroid administration, narcotic requirements, postoperative emesis, and cardiopulmonary complications in comparison to GA.
A reduction in systemic blood pressure frequently accompanies neuraxial blocks in adults, necessitating intervention. Nevertheless, spinal, caudal, or epidural blocks administered to children under six years old are not associated with any substantial alterations in blood pressure. In children aged 6 to 10, there is a linear decrease in blood pressure that will reach a plateau at approximately a 30% decrease in those beyond the age of 10. Conversely, younger children require no additional precautions.
Bupivacaine, has a narrow therapeutic index in children, and its dosing requires careful consideration to strike a balance between effective anesthesia and the risk of toxicity. The traditional method of dosing bupivacaine in pediatric spinal anesthesia is based on the child's body weight. This weight-based dosing considers the assumption that children's drug clearance correlates with their body mass. However, this approach might not account for the maturational changes in drug handling by pediatric patients or the variability in spinal column length and cerebrospinal fluid volumes, not always proportional to weight but may evolve with age.
Emerging evidence suggests that age-based dosing may be more effective. It hypothesizes that developmental pharmacokinetics, including changes in body composition, organ function, and drug-receptor differences, can influence bupivacaine metabolism and action more significantly than body mass alone. By accounting for the age-related anatomical and physiological changes, age-based dosing could result in more precise and effective anesthesia with a decreased risk of adverse outcomes.
To the authors knowledge, there is no study comparing age-based and weight-based bupivacaine dosing for pediatric spinal anesthesia in children undergoing elective infra-umbilical surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I and II
- •Both genders
- •Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
排除标准
- •Guardian refusal.
- •Children with major congenital heart disease, including septal defects.
- •Patients with neuromuscular disorders or high intracranial pressure.
- •Children with spinal deformities or morbid obesity (BMI above the 99th percentile).
- •Children with a history or family history of coagulation disorders.
- •Children with local infection at the site of skin puncture for spinal anesthesia.
- •Children with known allergy to bupivacaine.
- •Surgeries requiring head down (Trendelenburg) or prone position.
- •Unexpected prolongation of surgery > 90 minutes.
研究组 & 干预措施
Weight-based dosing
Hyperbaric bupivacaine 0.5% dosage will be calculated and administered intrathecally as 0.4 mg/kg or 0.08 ml/kg if body weight ≤ 15 kg and 0.3 mg/kg or 0.06 ml/kg if body weight > 15 kg
干预措施: Weight-based dosing (Drug)
Age-based dosing group
Hyperbaric bupivacaine 0.5% will be administered at the dose of age divided by 5 (in ml). The age in months after the completion of a year was noted and considered as the next age if it is more than 6 months and the same age if it is ≤ 6 months.
干预措施: Age-based dosing (Drug)
结局指标
主要结局
The peak sensory level
时间窗: 5 mins after intrathecal bupivacaine injection
The sensory level of subarachnoid block, tested by firm skin pinch.
次要结局
- Incidence of failed spinal blocks(2 hours from attempting subarachnoid block application)
- Block level time(10 minutes from intrathecal injection of local anesthetic)
- Postoperative pain score(3 hours from intrathecal injection of local anesthetic)
- Duration of the block(120 minutes from intrathecal injection of local anesthetic)
研究者
Kareem Mohammed Assem Nawwar
Lecturer
Cairo University