NCT02216266Unknown3 期
Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine
PD Dr. Bertram Scheller1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)
研究概览
简要总结
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aged > 18 years, < 85 years of ICU C1 after elective or emergency heart surgery with or without extracorporeal circulation (heart-lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine)
- •Patients (>18a, <85a) with CAM-ICU diagnosed delirium
- •Patients of legal capacity and patients with appointed representative
排除标准
- •hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen
- •gangrene mechanical obstipation
- •mechanical urinary retention
- •Dystrophia myotonica
- •Depolarization block after depolarising muscle relaxants
- •Intoxications with "irreversibly acting" cholinesterase inhibitors
- •closed head trauma
- •obstructions at gastro-intestinal tract and at urinary tract
- •neurological diseases
- •left ventricular ejection fraction < 40%
- •Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days
- •untreated coronary heart disease
- •wish to have children, pregnancy or nursing
- •patients with addictive disorder in medical history
研究组 & 干预措施
Physostigmine
Active Comparator
Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram
干预措施: Physostigmine (Drug)
Sodium Chloride solution
Placebo Comparator
solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram
干预措施: Sodium Chloride solution (Other)
结局指标
主要结局
change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)
时间窗: baseline to 48 hours after administration
次要结局
- reduction of weaning time at mechanical ventilator of patients with symptoms of delirium(baseline to 48 hours after administration)
- impact of the variability of heart rate(baseline to 48 hours)
- change in development of muscular force(baseline up to 48 hours)
- Occurence of Adverse events(baseline to 4 weeks after treatment)
- change in the spontaneous EEG and auditory evoked potentials(baseline to 48 hours after administration)
研究者
PD Dr. Bertram Scheller
PD MD Bertram Scheller
Johann Wolfgang Goethe University Hospital
研究点 (1)
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