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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The peak sensory level
研究概览
简要总结
This prospective randomized double-blinded controlled trial will include 60 pediatric patients aged 1 - 6 years old, both sexes, with American society of anesthesiologists (I and II) and undergoing elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes. Patients will be randomly divided into two equal groups: Weight-based dosing (Group A) and age-based dosing group (Group B). Both groups will receive hyperbaric bupivacaine 0.5%. The aim of the study is to evaluate the effectiveness of using age based dosing of Bupivacaine compared with standard method of weight based dosing in pediatric spinal anesthesia.
详细描述
This prospective randomized double-blinded controlled trial will be conducted on 60 pediatric patients who will undergo elective infra-umbilical surgeries, e.g., inguinal hernia repair, orchiopexy, etc. admitted to the operating theatres of Abu El Reesh Children's Hospital, Cairo University.
Randomization and blinding An online randomization program (http://www.randomizer.org) will be used to generate a random list, and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated in a 1:1 allocation ratio into two equal groups in a parallel manner:
- Group A (n=30): Children will receive spinal anesthesia according to weight-based dosing calculation of bupivacaine
- Group B (n=30): Children will receive spinal anesthesia according to age-based dosing calculation of bupivacaine. The patient and/or related guardian will be blinded to group assignment as well as the anesthesiologist involved in data collection and analysis. A physician who is not involved in the study prepared the interventional medications.
Methods:
All patients will be subjected to the followings:
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, Outcomes Assessor)
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
- •Children aged 1-6 years
- •Both genders.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
排除标准
- •Guardian refusal.
- •Children with significant congenital heart disease (e.g., septal defects requiring surgical intervention)
- •Children with neuromuscular disorders or high intracranial pressure.
- •Children with spinal deformities or morbid obesity (body mass index (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 Trendelenburg or prone position.
- •Unexpected prolongation of surgery > 90 minutes
研究组 & 干预措施
Group A: weight-based formula group
Children will receive spinal anesthesia according to the weight-based dosing calculation of Hyperbaric bupivacaine 0.5% as following: 0.4 mg/kg (0.08 ml/kg) for children weighing 5-15 kg or 0.3 mg/kg (0.06 ml/kg) for children weighing >15 kg
干预措施: Spinal Anesthesia with Bupivacaine (Procedure)
Group B: Age-based formula group
Children will receive spinal anesthesia according to the age-based dosing calculation of bupivacaine. Hyperbaric bupivacaine 0.5% will be calculated using Partha formula by dividing the child's age in years by 5. The resultant figure will be considered to be the dose of Bupivacaine in ml. If the number of months after the completion of a year in age is more than 6 months, the child's age will be noted to be the year older.
干预措施: Spinal Anesthesia with Bupivacaine (Procedure)
结局指标
主要结局
The peak sensory level
时间窗: Assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch up to 30 minutes after subarachnoid block
The peak sensory level will be assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch.
次要结局
- Time of completion of spinal block(starts immediately at the time of application of Betadine on the site of lumbar puncture to the time at which the patient is placed on their back after immediately administering the spinal anesthesia)
- Duration of spinal block(starts immediately after achieving a peak sensory and motor levels and eds immediately by the onset of perioperative pain or movement of legs)
- Postoperative pain score(Scale will be assessed postoperatively at 2 hours, 4 hours, and 6 hours from block administration.)
- The need for rescue analgesia in PACU(Postoperatively at 2 hours after spinal block and up to 1 hour postoperatively)
- Incidence of failure of spinal block(20 minutes after local anesthetic administration until 30 minutes after local anesthetic administration)
- Complications related to anesthesia(started immediately after lumbar puncture and followed up for 2 hours postoperatively)
- Incidence of intraoperative complications(Started immediately after spinal block until the end of surgery)
研究者
Hany Mohammed El-Hadi Shoukat Mohammed
Assistant Professor
Cairo University