NCT03739476终止3 期
Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年2月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.
研究概览
简要总结
Double blinded Clinical trial to test efficacy of Quetiapine versus placebo in reducing postoperative delirium in high risk surgical patients after three days of treatment.
详细描述
This study evaluates postoperative delirium in high risk surgical patients to know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.
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
- Double (Participant, Investigator)
盲法说明
double blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 65 years-old patients who will be undergoing major surgery (noncardiac) and having an equal or greater score of 5 on the scale Delphi.
- •Age: 70-79 years: 1 point; ≥80 years: 2 points.
- •Physical activity: need for assistance, not self-sufficient: 2 point.
- •Alcoholism: 1 point.
- •Hearing Impaired: 1 point.
- •History of delirium: 2 points.
- •Emergency surgery: 1 point.
- •No laparoscopic surgery: 2 points.
- •Admission critical Units: 3 points.
- •Value of C-reactive protein (CRP) ≥ 10 milligrams (mg) / decilitre (dL): 1 point
排除标准
- •Allergy to quetiapine.
- •Patients with a score less than 5 on the Delphi scale.
- •Diagnosis of delirium at admission.
- •Cardiological diseases: corrected QT interval (QTc) ≥ 460 millisecond (msec) in men, ≥ 470 msec in women, recent myocardial infarction or cardiac decompensation, 2-3° degree atrioventricular block or history of torsades de pointes arrhythmias or ventricular arrhythmias, bradycardia...
- •Hypokalemia ≤ 3 milliequivalent (mEq) / Potassium chloride (KCl).
- •History of drug use.
- •Patients on Antipsychotic or antidopaminergic treatment (chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, paliperidone, amisulpride).
- •Parkinson's disease.
- •Test MINIMENTAL ≤
- •Corps or vascular dementia Levi.
- •Hypokinetic movement disorder.
- •History of neuroleptic malignant syndrome.
- •Central Anticholinergic Syndrome.
- •Epilepsy.
- •Patients with a wight less than 50 or greater than 200 kg (kilograms).
研究组 & 干预措施
Interventional
Experimental
Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days
干预措施: Quetiapine 25 milligrams capsule (Drug)
control
Placebo Comparator
Placebo 1 hour after surgery and each 12 hours for 3 days
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.
时间窗: 28 (± 2) days from the start of treatment in each patient.
Proportion of patients diagnosed with delirium (number of cases of delirium / total number of patients) within the first four days in both arms. 65 years, treated early with prophylactic quetiapine versus placebo.
次要结局
- Degree of sedation.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Perceived general well-being.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Days without delirium, if it appears.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Duration of delirium, if it appears.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Severity of delirium measured with a validated scale. time of appearance the duration and severity. use of another antipsychotics.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Dose of other antipsychotic (haloperidol).(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Measurement of corrected QT interval (QTc) prolongation.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Evaluation of extrapyramidal symptoms.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Days in hospital from surgery.(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
- Mortality (all causes)(28 ± 2 days from the start (first dose) of treatment with quetiapine.)
研究者
研究点 (1)
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