NCT02096068已完成4 期
Neuroprotection With Dexmedetomidine in Patients Undergoing Elective Cardiac or Abdominal Surgery (NEUPRODEX)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The drug Dexmedetomidine will be investigated in 72 patients (men and women) undergoing elective cardiac or abdominal surgery. The study medication will be administered perioperatively by intravenous infusion continuously (at the longest 48 h) to prevent/reduce the rate of Delirium and the incidence of postoperative cognitive deficit (POCD).
A non-surgical control group of 15 ASA II/III- patients from Berlin and surrounding area is collected for measuring the learning experience during the cognitive testings. The participants are matched on age, education, and gender to the study patients.
Cognitive testings are performed in patients of the study group (n= 72) and the control group (n= 15) to evaluate deficits in their cognitive areas (POCD (Postoperative cognitive deficit)) at three different time points up to three months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 60 years
- •Male and female patients undergoing elective cardiac (elective CABG-surgery without valve surgery with left ventricular ejection fraction ≥ 30%) or pancreatic or hepatic or gastric or intestinal surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin
- •Offered patient information and written consent by the patient (according to German Drug Law § 40 (1) 3b)
- •Premedication only with benzodiazepines
- •Pain therapy during the operation with regional procedures and/or Sufentanil/Fentanyl
- •Anesthesia in cardio surgery according to Heart-Lung-Apparatus
- •Anesthesia with hypnotic agent Propofol
- •Pain therapy after operation according to S3-Guideline
- •Postoperative medication for anxiolysis only with benzodiazepines
排除标准
- •Known drug intolerance/allergy: dexmedetomidine or to other ingredients
- •Lacking willingness to save and hand out pseudonymised data within the clinical trial
- •Accommodation in an institution due to an official or judicial order (according to AMG §40 (1) 4)
- •Employee of the Charité - Universitätsmedizin Berlin CVK/CCM
- •Inability to speak and/or read German
- •Minimal mental status examination (MMSE) < 24
- •Severe hearing loss or visual impairment
- •Acute brain injury
- •Intracranial haemorrhage within one year before participation in the study
- •Manifest psychiatric disease
- •Known illicit substance abuse
- •Acute intoxication
- •For women: Pregnancy or positive pregnancy test within the preoperative screening
- •Homeless or other circumstances, where the patient would not be reachable by telephone or postal services for the 3-months follow up
- •Participation in another interventional clinical trial according to the German Drug Law at time of inclusion and during the trial
- •Acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite vasopressors or optimal preload)
- •AV-conduction-block II or III (unless pacemaker installed)
- •Severe bradycardia (heart-rate < 50 bpm, preoperative, permanent)
- •Spinal cord injury with known autonomic dysregulation
- •Preoperative acute cerebrovascular event with neurologic residues
- •Liver insufficiency (Child C cirrhosis, MELD Score > 17)
- •Application of Remifentanil during the operation
- •Deep sedation (RASS, -4 to -5)
- •Administration of Clonidine during administration of the study drug
- •Additional administration of Dexmedetomidine within 3 months after study inclusion
- •Control Group:
- •Inclusion Criteria:
- •Patients aged ≥ 60 years of European descent (Caucasian)
- •Male or female patients with ASA II+III
- •ASA II+III-patients, for which no operation is planned within the next year
- •No operation in the last half year before study inclusion
- •Offered patient information and written informed consent
- •Exclusion Criteria
- •Minimal mental status examination (MMSE) < 24
- •Missing informed consent for saving and hand out pseudonymous data
- •Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing
- •Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing
- •Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis and other substances, which limit the conduction of the neurocognitive testing
研究组 & 干预措施
Study group
Experimental
Application of Dexmedetomidine (Dexdor®) perioperatively for a maximum of 48 hours
Dosing Scheme:
during operation and mechanical ventilation: 0,7μg/kgABW/h; recovery time until extubation: 0,4μg/kgABW/h; after extubation: 0,2-1,4μg/kgABW/h
干预措施: Dexmedetomidine (Dexdor®) (Drug)
Control group
Placebo Comparator
Application of placebo for a maximum of 48 hours
干预措施: 0.9% Sodium Chloride (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Until the 5th postoperative day
Incidence of postoperative delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU) or the Confusion Assessment Method (CAM)
次要结局
- Severity of illness(Up to 14 postoperative days)
- Duration of delirium in the intensive care unit(Until the 14th postoperative day/discharge)
- Severity of anxiety(Up to three months)
- Management of vigilance(Until the 5th postoperative day)
- Intraoperative cerebral oxymetry(At time of surgery)
- Incidence of subsyndromal delirium and severity of postoperative delirium(Until the 14th postoperative day/discharge)
- Management of sedation(Until the 5th postoperative day)
- Mechanical ventilation/weaning failure(Until the 5th postoperative day)
- Incidence of postoperative cognitive dysfunction(Up to three months)
- Mortality(Up to three months)
- Sleep quality(Up to three months)
- Relevant medication(Until the 5th postoperative day)
- Organ dysfunctions(Up to three months)
- ICU length of stay(Participants will be followed for the duration of intensive care stay, an expected average of 2 days)
- Hospital length of stay(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Quality of life(Up to three months)
- Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography(At time of surgery)
- Management of analgesia and pain levels(Up to three months)
- Determination of blood levels(Change from baseline complete blood count performance (Sysmex®) and acetylcholinesterase-analysis at third postoperative day)
- Cortisol-analysis(Up to three months)
- Infections(Up to three months)
- Processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®)(At time of surgery)
- Photomotor reflex(At time of surgery)
研究者
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine CVK/CCM
Charite University, Berlin, Germany
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing CABGDelirium on EmergenceNCT03477994Ain Shams University147
已完成
不适用
Dexmedetomidine on Brain Injury PatientsBrain InjuriesNCT06661980Damanhour University60
已完成
4 期
Co-administration of Dexmedetomidine in Carotid Endarterectomy (CEA)Carotid StenosisNCT04662177Insel Gruppe AG, University Hospital Bern23
招募中
不适用
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial InfarctionST-segment Elevation Myocardial Infarction (STEMI)Percutaneous Coronary InterventionCardioprotectionNCT04912518Harbin Medical University250
Unknown
不适用
Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft SurgeryCoronary Artery DiseaseNCT01704092Huazhong University of Science and Technology90