CONTROLLED, DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL FOR PROPHILAXIS OF POSOPERATIVE DELIRIUM IN HIGH RISK SURGICAL PATIENTS WITH QUETIAPINE.
- Conditions
- Postoperative delirium in high risk surgical patients.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-004117-27-ES
- Lead Sponsor
- IBSAL (Instituto de Investigación Biomédica de
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.;Secondary Objective: - Evaluate the safety and tolerability of the medication applied.<br>- Compare the efficacy of medication versus placebo in relation to:<br> the length of hospital stay.<br> perceived quality of life.<br> mortality (all causes) at discharge and at 28 ± 2 days from the start (first dose) of treatment with quetiapine.<br>- In case of posoperative delirium , know:<br> time of appearance<br> the duration and severity.<br> total dose of treatment with other antipsychotics.;Primary end point(s): Proportion of patients diagnosed with delirium (number of cases of delirium / total number of patients) within the first four days in both arms.;Timepoint(s) of evaluation of this end point: 28 (± 2) days before the start of treatment in each patient.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Number of days from the start of treatment until delirium, if it appears.<br>- Duration of delirium, in days.<br>- Severity of delirium measured with a validated scale (DRS-R-98).<br>- Total dose (mg) of other antipsychotic (haloperidol) to control symptoms of delirium.<br>- Security variables:<br> degree sedation: by RASS scale.<br> QTc prolongation: increased msec ECG control.<br> presence or absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity).<br>- Days in hospital from surgery.<br>- Perceived quality of life (using validated questionnaire SF36) at 28 (± 2) days before the start of treatment<br>- Mortality (all causes) at discharge and at 28 (± 2) days before the start of treatment.;Timepoint(s) of evaluation of this end point: 28 (± 2) days before the start of treatment in each patient.