Opioid Sparing Analgesia: Intraoperative Infusion Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Intraoperative total fentanyl consumption.
研究概览
简要总结
Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future.
Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.
详细描述
Site of study:
This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals.
b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 6-18 years old.
- •Sex: both sexes.
- •Physical status: American Society Of Anesthesiologist 1& II.
- •Body Mass Index >5 th and < the 85th percentile for age.
- •Type of operations: elective intracranial surgeries under general anesthesia.
- •Duration of operation < 3 hours.
- •Written informed consent from the parent of child
排除标准
- •Altered mental state
- •Unsuitability for extubation.
- •Patients on beta blocker, alpha 2 agonist.
- •Patients on pain killer or with known history of allergy to study drugs.
- •Hepatic, renal, Cardiovascular and respiratory disease.
- •The patient has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
研究组 & 干预措施
dexmedetomdine
IV bolus dose of 0.5ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5ug/kg/h
干预措施: Dexmedetomidine injection (Drug)
lidocaine
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
干预措施: Lidocaine Iv (Drug)
结局指标
主要结局
Intraoperative total fentanyl consumption.
时间窗: from induction till end of surgery up to 3 hours intraoperative.
Intraoperative fentanyl 0.5ug/ kg when the heart rate and mean arterial blood pressure of patients increased \> 20% from basal measurement after exclusion of other causes.
次要结局
- side-effects(up to 12 hour postoperative)
- pain intensity(immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative.)
- Time to first call for rescue analgesic (fentanyl)(up to one hour postoperative)
- level of sedation(up to one hour postoperative)
- Total amount of nalbuphine consumption(up to twelve hours postoperative)
- The duration of Post Anesthesia Care Unite stay(up to 2 hour postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
lecturer of Anaesthesia ,and surgical intensive care
Zagazig University