Loading clinical trials...

Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients

Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine

NCT03739476•Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (1)

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Key Dates

Start Date

February 13, 2019

Primary Completion Date

April 2, 2020

Completion Date

June 30, 2020

Last Updated

May 22, 2025

Enrollment

ACTUAL participants

Conditions

Postoperative Delirium

Interventions

Quetiapine 25 milligrams capsule

DRUG

Placebo oral capsule

DRUG

Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

NCT07323485

Postoperative DeliriumPediatric Anesthesia+1 more

View study

RECRUITING

Naples Prognostic Score for Predicting Postoperative Delirium

NCT07297017

Postoperative Delirium

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients

Inclusion Criteria

Exclusion Criteria

Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

Naples Prognostic Score for Predicting Postoperative Delirium

Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries

The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium

Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms