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 range

65 Years

Sex

ALL

See this in plain English?

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-02

View on ClinicalTrials.gov More Postoperative Delirium trials

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.