Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
研究概览
简要总结
The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.
详细描述
The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years and older
- •Signed agreement
排除标准
- •Delirium at admittance or MMSE score <24 points
- •High risk for postoperative ICU treatment
- •Haloperidol or Ketamine intolerance
- •Risk of lack of cooperation
- •Drug an alcohol abuse
- •QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
- •Parkinson's disease
- •Intake of dopaminergic drugs (Levodopa, dopamine agonists)
- •Parkinsonism
- •Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
- •Delay of operation of more than 72 hours past hospital admittance
- •Body weight >100kg
研究组 & 干预措施
Haloperidol
Haloperidol 0.005mg/kg at induction of anesthesia
干预措施: Haloperidol (Drug)
Ketamine
Ketamine 1mg/kg at induction of anesthesia
干预措施: Ketamine (Drug)
Haloperidol + Ketamine
Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia
干预措施: Haloperidol + Ketamine (Drug)
Saline solution (NaCl 0.9%)
Placebo
干预措施: Saline solution (NaCl 0.9%) (Drug)
结局指标
主要结局
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
时间窗: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
次要结局
- Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters(5 day follow-up (preoperative, day of surgery, postoperative days 1-3))