Effect of Adding Different Concentrations of Dexmedetomidine to Bupivacaine in Caudal Block for Pediatrics Undergoing Inguinal Hernia Repair
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The duration of analgesia
研究概览
简要总结
Pain is one of the medical problems frequently misdiagnosed, undertreated, and poorly under-stood, particularly in children.Poor pain management during childhood may have long-term deleterious impacts, including damaging neuro-endocrine reactions, disturbed eating and sleeping pat-terns, and increased pain sensitivity during subsequent painful events.
A caudal epidural block is a common regional analgesic technique in pediatric surgery . It is a time-tested, safe, and efficacious technique However, the duration of post-operative pain seen with much pediatric surgery (>24 h) outlasts the duration of analgesia afforded by a standard 'local-anesthetics only' caudal block (4-12 h) While continuous catheters prolong analgesic duration, such techniques are more cumbersome, require significant technical expertise and may be associated with higher adverse events. Contrary to this, adding adjuvants to local anesthetic is an appealing alternative. Adjuvants can improve the block and analgesic duration , reduce general anesthetic or local anesthetic requirements, allow for smoother emergence, lower incidence of emergence delirium, and facilitate early discharge in ambulatory surgery.
Various adjuvants have been shown to enhance caudal blocks with varying degrees of success. A multitude of clinical trials and meta-analyses have analyzed the efficacy of different adjuvants such as alpha-2 agonists (clonidine and dexmedetomidine ), N-methyl-D-aspartate (NMDA) antagonists (ketamine and magnesium ), opioids (fentanyl, morphine, and tramadol ), corticosteroids (dexamethasone ), and acetylcholine esterase inhibitors (neostigmine).
Dexmedetomidine has become more popular as a caudal adjuvant in children; it is a highly selective α2 agonist with sedative and analgesic properties. Dexmedetomidine possesses anxiolytic, sedative, sympatholytic, and analgesic properties without respiratory depressant effects In addition; dexmedetomidine has the ability to reduce both the anesthetic and opioid analgesic requirements during the perioperative period.
详细描述
Anesthetic technique All children will be fasted for at least six hours before surgery, with clear fluids allowed until two hours before induction. Heart rate, non-invasive blood pressure, and oxygen saturation will be monitored in the operating room. The anesthetic regimen will be standardized. All participants will be pre-oxygenated with 100% oxygen for 3 min via a facemask.
Both groups will receive 0.5 mg/kg of midazolam orally as a premedication half an hour before induction. Anesthesia induction will be achieved by incremental 1.5% doses of sevoflurane up to 7% in a 50% oxygen/air mixture. After establishment of intravenous line, intravenous fentanyl (1μg/kg) and propofol (2mg/kg) will be given. After induction 0.5 mg/kg atracurium will be given to facilitate endotracheal intubation; an endotracheal tube of appropriate size will be inserted; and controlled ventilation will be adjusted to maintain end arterial CO2 around 35 mmHg. Anesthesia will be maintained with sevoflurane 2% in a 50% oxygen/air mixture.
Caudal block After anesthesia is administered and the patient is stabilized, he will be placed in the left lateral decubitus position, the sacrococcygeal area will be sterilized with povidone-iodine solution, and sterile wraps will be applied. A 22-gauge hypodermic needle will be used to locate the caudal epidural area. After aspiration without blood or CSF and confirmation of the caudal epidural space using the modified Swoosh test, the medication mixture will be administered.
Adequate analgesia during surgery will be defined by hemodynamic stability according to the absence of greater than 20% increases in heart rate or systolic blood pressure from baseline values obtained immediately before the first surgical incision. Patients with unsuccessful blocks will be excluded from the study.
At the end of the operation, neostigmine 50 mcg/kg and atropine 15 mcg/kg will be used to reverse the action of the muscle relaxant, and sevoflurane will be discontinued. All patients will be extubated and transported to the post-anaesthesia care unit. Participants will be discharged from the PACU to a ward once the modified Aldrete score is nine or greater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA I and II,
- •aged 1-6 years
- •scheduled for elective inguinal hernia repair
排除标准
- •Guardians refusal
- •Contraindication to caudal block like :
- •Patients with congenital anomalies at the lower spine or meninges
- •Patients with increased intracranial pressure
- •Patients with skin infection at the site of injection
- •Patients with bleeding diathesis
- •Know allergy to any drug used in this study
- •Patients with cardiopulmonary disease
- •Patients with other congenital anomalies
- •Patients with developmental delay
研究组 & 干预措施
Group A: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 0.
干预措施: Dexmedetomidine (Drug)
Group A: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 0.
干预措施: Bupivacain (Drug)
Group B: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 1
干预措施: Dexmedetomidine (Drug)
Group B: 25 patients will receive caudal block with 1 ml/kg bupivacaine 0.25% and dexmedetomidine 1
干预措施: Bupivacain (Drug)
结局指标
主要结局
The duration of analgesia
时间窗: baseline and 24 hours
次要结局
- Total analgesic consumption(baseline and 24 hours)
- any neurological adverse effects(baseline and 24 hours)
研究者
Ahmed Gamal Mahmoud Hamed
Resident
Assiut University