Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period.
研究概览
简要总结
The relationship between the target effect site concentration of remifentanil and the pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extra corporeal circulation will be evaluated.
详细描述
Anaesthesia will be induced with propofol to obtain loss of consciousness LOC in 30 patients who will undergo cardiac surgery requiring extracorporeal circulation and standardized support will be given to them till the extracorporeal circulation period. Thereafter, remifentanil will be titrated by increments of 0,5, from 1 up to 5 ng ml-1 during the extra corporeal circulation period. In the awake state, at LOC and at each plateau level of remifentanil CeT, mean arterial pressure, and BIS will be recorded. Pupil size and dilatation after a 60 mA, 100 Hz tetanic stimulation will be measured at LOC and at each plateau level of remifentanil.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •general anesthesia for cardiac surgery programmed requiring the realization of a sternotomy and the use of extra corporeal circulation
- •age> 18 years
排除标准
- •contraindication to the use of the products defined in the protocol of anesthesia (alprazolam, remifentanil, propofol, atracurium)
- •sedation in progress with use of morphinomimetics
- •urgent surgery
- •preoperative existence of circulatory assistance
- •preoperative existence of an intra-aortic balloon pump,
- •bilateral ocular pathology (severe cataract, amblyopia, glaucoma, keratitis, conjunctivitis) and / or history of bilateral ocular surgery affecting the iris
- •history of epilepsy, cerebral palsy
- •peripheral neuromuscular diseases
- •pathology with dysautonomia impairing the pupillary dilation reflex: insulin-dependent type 1 or type 2 diabetes with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, advanced Parkinson's disease
- •ongoing treatment interfering with the autonomic and central nervous system likely to alter the pupillary dilation reflex: antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine, dexmedetomidine), high doses of nitrous oxide
- •treatment with severe anticholinergic effect: such as amitriptyline, amoxapine, atropine, benztropine, chlorpheniramine, chlorpromazine, clemastine, clomipramine, clozapine, darifenacin, desipramine, dicyclomine, diphenhydramine, doxepin, flavoxate, hydroxyzine, hyoscyamine, imipramine, meclizine, nortriptyline, orphenadrine, oxybutynin, paroxetine, perphenazine, procyclidine, promazine, promethazine, propentheline, pyrilamine, scopolamine, thioridazine, tolterodine, trifluoperazine, trihexyphenidyl, trimipramine
- •pregnant or lactating women
- •Patient having objected to the processing of his data
结局指标
主要结局
Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period.
时间窗: During surgery / one day
To prove the existence of a linear correlation between the change in pupillary diameter and the concentration of remifentanil in cardiac surgery during the extracorporeal circulation period
次要结局
- Validity of pupillometry nociception measurements in moderate hypothermia(During surgery / one day)