Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients (NCT03739476) | Clinical Trial Compass
TerminatedPhase 3
Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
Stopped: Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.
Spain54 participantsStarted 2019-02-13
Plain-language summary
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.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 ≤ 24.
* Corps or vascular dementia Levi.
* Hypokinetic movement disorder.
* History of neuroleptic malignant syndrome.
* Central Anticholinergic Syndrome.
* Epilepsy.
* Patients with a wight less …
What they're measuring
1
To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.
Timeframe: 28 (± 2) days from the start of treatment in each patient.
Trial details
NCT IDNCT03739476
SponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León