Monocentric, Prospective Randomized Controlled Clinical Trial Assessing the Effect on the Lower Limb Spinal Motoneuron Excitability, the Efficacy in Term of Morphinic Sparing and Safety of of Early Clonidine Bolus Intravenous Administration During General Anesthesia in Children and Adolescent 6-18 Years Old Requesting Reconstructive Tympanic Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.
研究概览
简要总结
The purpose of this study is to assess the effect of IV clonidine administration on lower limb spinal motoneuron excitability during standardized total intravenous anesthesia (propofol and remifentanil).
详细描述
According to the literature data, intraoperative administration of clonidine reduces the need for morphine per and postoperative and thus reduces the side effects associated related to their administration.
Nevertheless, on the basis of current knowledge, clonidine may disrupt some electrophysiological measures required for the intraoperative monitoring of surgeries with a high risk of neurological complications.
For such surgery, anaesthesiologists are led to inject clonidine after surgery, at a time when the electrophysiological measures are no longer needed, which limits the benefit in terms of intraoperative morphine savings.
Whith this study, investigators would like to investigate if an early administration of clonidine in patients aged 6 to 16 years undergoing ear surgery disturbs excitability of the spinal motor neuron.
The choice of the study population is justified by the fact that the ear surgery does not require electrophysiological monitoring and it is carried out under conditions similar to that of anesthesia of scoliosis corrective surgery for which electrophysiological measurements are essential for the prevention of neurological complications.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Patients aged 6 to 18 years at time of hospital admission
- •Planned hospital admission for tympanoplasty
- •Informed Consent signed by both parents
排除标准
- •Known hypersensitivity to clonidine or to any component of the Catapressan
- •Patient treated with alpha2 agonists
- •Surgical emergency
- •Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
- •Abnormal heart rhythms
- •Neuromuscular disease
- •Renal impairment
- •Patient treated with methylphenidate
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Test Group
Patients randomized in the Test Group will receive the clonidine hydrochloride
干预措施: Clonidine hydrochloride (Drug)
Control Group
Patients randomized in the Control Group will receive the Placebo
干预措施: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level (Other)
结局指标
主要结局
Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.
时间窗: continuously during the surgery
Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration
时间窗: continuously during the surgery
次要结局
- Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale(Every 30 minutes during the recovey period (up to 2H))
- Total dose of step 2 analgesic (tramadol) used for pain management(Total dose given during the recovery period (up to 2H))
- Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period(perioperative period, up to 5H)
- Sedative score using the University of Michigan Sedation Scale (UMSS) scale(Every 30 minutes during the recovery period (up to 2H))