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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

NCT02297763

Delirium

UNKNOWN PHASE3

Quetiapine as Prophylaxis for Delirium in CABG

NCT05801289

Delirium

UNKNOWN NA

Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

NCT02612948

Psychomotor Agitation

COMPLETED PHASE4

Postoperative Delirium in the ICU Setting of an Eastern European Centre

NCT05474872

Postoperative Delirium Cognitive Impairment

RECRUITING

The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients

NCT05140993

Postoperative Delirium

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one arm treatment. one arm placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional

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

Group Type EXPERIMENTAL

Quetiapine 25 milligrams capsule

Intervention Type DRUG

Compare the incidence of postoperative delirium.

control

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Compare the incidence of postoperative delirium.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine 25 milligrams capsule

Compare the incidence of postoperative delirium.

Intervention Type DRUG

Placebo oral capsule

Compare the incidence of postoperative delirium.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Experimental arm Control arm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 than 50 or greater than 200 kg (kilograms).

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No