Trial | NCT03739476  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    50
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.
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.
Study Started
Feb 13
2019
Primary Completion
Apr 02
2020
Study Completion
Jun 30
2020
Last Update
Jun 14
2022

Drug Quetiapine 25 milligrams capsule

Compare the incidence of postoperative delirium.

  • Other names: Experimental arm

Drug Placebo oral capsule

Compare the incidence of postoperative delirium.

  • Other names: Control arm

Interventional Experimental

Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days

control Placebo Comparator

Placebo 1 hour after surgery and each 12 hours for 3 days

Criteria 

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: 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 than 50 or greater than 200 kg (kilograms).
No Results Posted