CONTROLLED, DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL FOR PROPHILAXIS OF POSOPERATIVE DELIRIUM IN HIGH RISK SURGICAL PATIENTS WITH QUETIAPINE. - QUEPRO

IBSAL (Instituto de Investigación Biomédica de0 个研究点目标入组 350 人开始时间: 2017年12月18日最近更新: 2022年5月9日

试验速览

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•Greater than or equal to 65 years-old patients who will be undergoing major surgery (noncardiac) and having an equal or greater score of 7 on the scale Delphi:
•- Age: 70-79 years: 1 point; =80 years: 2 points
•- Physical activity: need for assistance, not self-sufficient: 1 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 mg / dL: 1 point
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 350

•- Allergy to quetiapine.
•- Patients at low risk of developing delirium at admission.
•- Diagnosis of delirium at admission.
•- Cardiological diseases: qtc > 460mseg in men, > 470 msec in women, recent MI or cardiac decompensation, 2-3 ° AV block or history of torsades de pointes arrhythmias or ventricular arrhythmias, bradycardia...
•- Hypokalemia <3 mEq / CLK.
•- History of drug use.
•- Patients on Antipsychotic or antidopaminergic treatment (chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, paliperidone, amisulpride).
•- Parkinson's disease.
•- Test MINIMENTAL <24.
•- 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.

发起方

IBSAL (Instituto de Investigación Biomédica de