A Comparative Study of the Effect of Propofol Infusion Versus the Combination of Ketamine and Dexmedetomidine Infusion on the Amplitude of Motor Evoked Potential in Pediatrics Undergoing Tethered Spinal Cord Surgeries a Randomized, Double-blinded Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- the mean microvolts of 3 measurements of MEPs at 5 minutes interval at AH muscle before skin incision.
研究概览
简要总结
The tethered spinal cord is a common pathology in pediatric neurosurgery. Intraoperative neurophysiologic monitoring (IOM) has gained popularity over the past two decades as a clinical discipline that uses neurophysiologic techniques to detect and prevent iatrogenic neurologic injuries. IOM techniques are extensively used in adult neurosurgery and, in their principles, can be applied to the pediatric population. Inhalational agents cause a dose-dependent reduction in MEPs and are arguably considered incompatible with effective neurophysiological monitoring(5) For this reason, total intravenous anesthesia (TIVA), using IV anesthetics (propofol or ketamine) and opioids (fentanyl or remifentanil), is commonly used in spinal surgeries under MEPs monitoring
详细描述
A combination of ketamine and dexmeditomidine has several benefits in terms of hemodynamic stability, absence of respiratory depression, postoperative analgesia, and recovery. (11) ketamine could prevent the decrease of blood pressure and heart rate which had been observed with dexmedetomidine. In addition, dexmedetomidine could prevent the increase of blood pressure and heart rate, salivation, and physiological emergence reaction from ketamine. This combination was not previously used in this type of procedure except in a case report performed by Rozzana Penny who had used dexmedetomidine and ketamine infusion during scoliosis repair surgery with somatosensory and motor evoked potential monitoring in 15 years old female.(10) Evoked potentials are highly sensitive to fluctuations in physiological parameters such as peripheral and core body temperature, arterial blood pressure, hematocrit, etc. Keeping in view all the above factors we plan this study to compare the effect of the combinations of propofol and fentanyl versus the combination of ketamine and dexmedetomidine and fentanyl in producing a minimum effect on MEP amplitude and on hemodynamic stability during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
. The details of the series will be unknown to the investigators and the group assignment will be kept in a set of sealed envelopes, each bearing only the case number on the outside. a person who will prepare the drugs and data collector is not one of the trial investigators.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with ASA I and II presented to Abu elreesh hospital for untethered spinal cord surgery.
排除标准
- •Children with neuromuscular diseases or congenital scoliosis.
- •Children with growing rod distraction surgery.
- •Children with American Society of Anaesthesiologists (ASA) physical status III, IV
- •Children with preoperative use of antidepressant or anticonvulsant medications.
- •Children with a known history of drug allergies.
研究组 & 干预措施
Ketamine-dexmedetomidine group
Dexmedetomidine( 0.4 -0.6 μg/.kg /.h r)) ketamine,( 1-2m/.kg/.hr) infusion and giving bolus of fentanyl,( 1-2μg/.kg/ ) with keeping mean arterial blood pressure and heart rates changes within 25% of the baseline.
干预措施: ketamine and dexmeditomidine combination (Drug)
propofol group
propofol (100 ug/kg/min) -giving a bolus of fentanyl, (1-2μg/.kg/ ) with keeping mean arterial blood pressure and heart rate changes within 25% of the baseline.
干预措施: Propofol (Drug)
结局指标
主要结局
the mean microvolts of 3 measurements of MEPs at 5 minutes interval at AH muscle before skin incision.
时间窗: 2 hours
the amplitude of motor evoked potentials measures
次要结局
- fentanyl consumption in micrograms(2 hours)
- Measurement of MEP at baseline once the patient will be prone , at surgical incision , and once exposure of the spine will be complete and during spinal manipulation and At the end of the surgery.(2 hours)
- Measurements of blood pressure at base line T1, induction (T2) positioning( T3), skin incision (T4) , during spinal manipulation (T5)and by the end of the surgery (T6).(2 hours)
- First rescue of analgesia(2 hours)
- Side effects (sedation -hypotension ( MAP less than 25% from the baseline reading) - bradycardia - respiratory depression)(6 hours)
- Measurements of heart rate at baseline T1, induction T2, positioning T3,spinal manipulationT4,at the end of surgery T5(2 hours)
研究者
Amany Hassan Saleh
Associate professor of anesthesia ,surgical intensive care and pain management ,Cairo University
Cairo University