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临床试验/NCT05902780
NCT05902780尚未招募不适用

Can Caudal Dexmedetomidine Provide Effective Analgesia During Pediatric Inguinoscrotal Surgery?

Benha University0 个研究点目标入组 50 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Time to the first analgesic rescue

研究概览

简要总结

The goal of this clinical trial is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics, if used caudally alone (and not as an adjunct to caudal bupivacaine).

The main question it aims to answer is:

  • Can caudal dexmedetomidine provide effective analgesia? Participants will be pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries.
  • A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups:
  • Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg.
  • Group D (n =25): In this group, and after injection of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.

详细描述

• Introduction

  • Caudal anesthesia is a relatively low-risk technique commonly used, either on its own or in combination with sedation or general anesthesia.
  • Caudal anesthesia is one of the most used-popular regional blocks in children. This technique is a useful adjunct during general anesthesia and for providing postoperative analgesia after infra-umbilical operations.
  • Caudal blocks performed on sedated children, enable not only early ambulation, but also periprocedural hemodynamic stability and spontaneous breathing in patient groups at maximum risk of a difficult airway. These are important advantages over general anesthesia, notably in preterm babies and in children with cardiopulmonary co-morbidities. Caudal epidural anesthesia has been shown to reduce stress response and shorten the time for extubation in children.
  • Caudal anesthesia is indicated for surgical and non-surgical painful interventions in body areas from the sub-umbilical region downwards. Examples include procedures such as inguinal hernia repair, cystoscopy/transurethral manipulation, circumcision, anal atresia, treatment of limb ischemia, treatment of intussusception, or cast application to immobilize newborns with hip dysplasia.
  • Contraindications to caudal anesthesia in children would include local site infection, pilonidal cyst, or spinal dysraphism such as tethered cord syndrome.
  • Bupivacaine (an amide local anesthetic) has provided reliable anesthesia and analgesia.
  • Bupivacaine is the indicated local anesthetic in caudal, epidural, and spinal anesthesia and is widely used clinically to manage acute and chronic pain. In addition to blocking Na+ channels, bupivacaine affects the activity of many other channels, including NMDA receptors.
  • Adverse effects of bupivacaine includes local anesthetic systemic toxicity, urinary retention, high block, hypotension, delayed respiratory depression, and cardiac arrest.
  • Dexmedetomidine is an alpha agonist having sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties. It produces these effects by inhibiting central sympathetic outflow by blocking the alpha receptors in the brainstem, thereby inhibiting the release of norepinephrine.
  • Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, which binds to transmembrane G protein-binding adrenoreceptors in the periphery (α2A), brain, and spinal cord (α2B, α2C) tissues.

In contrast to other sedative agents, dexmedetomidine, by acting on α2 receptors in the locus caeruleus, has potential analgesic effects without respiratory depression.

  • Dexmedetomidine seems to help to reduce the time for extubation.
  • Dexmedetomidine is also an adjunct infusion during general anesthesia. There is evidence that dexmedetomidine decreases postoperative pain, postoperative opioid usage, and nausea. This effect has also been shown to be present when using dexmedetomidine for sedation during procedures performed under spinal anesthesia. There has been some interest in using dexmedetomidine as an adjunct to prevent emergence agitation, postoperative delirium, and postoperative cognitive dysfunction. There is evidence for the prevention of emergence agitation in both children and adults.
  • The most common adverse effects of dexmedetomidine are hypotension and bradycardia which result from the stimulation of presynaptic alpha receptors, which leads to a decreased release of norepinephrine; this is in addition to the decrease in the central sympathetic outflow. These are concerns regardless of the route of administration.

Ethical consideration :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA-I and ASA-II pediatric patients (age :1-6 years old)
  • Inguinoscrotal surgeries

排除标准

  • Patient's parent's refusal
  • Unable to give consent
  • Known allergy to the study medications
  • Coagulopathies or on anticoagulant medications
  • ASA-III or ASA-IV

研究组 & 干预措施

Group B (25 patients)

Active Comparator

In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg.

干预措施: Caudal Bupivacaine injection (Drug)

Group D (25 patients)

Active Comparator

In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.

干预措施: Caudal Dexmedetomidine Injection (Drug)

结局指标

主要结局

Time to the first analgesic rescue

时间窗: during the first 6 hours postoperative

Measure time in minutes (min) till the patient needs opioids for the first time postoperative

Amount of opioids needed by patients.

时间窗: during the first 6 hours postoperative

How much opioids in mcg/kg will the patient needs

次要结局

  • Blood pressure(Preoperative,Intraoperative and 2 hours postoperative)
  • Presence of respiratory depression(2 hours Postoperative every 10 min)
  • Heart rate(Preoperative, intraoperative, and 2 hours postoperative)
  • Emergence agitation(Intraoperative with extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nourhan Elsayed Mohamed Amer

Lecturer of Anesthesia at Faculty of Medicine, Benha University

Benha University

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