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

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

Status and phase: Terminated; Phase 3

Conditions: Postoperative Delirium

Treatments: Drug: Quetiapine 25 milligrams capsule; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03739476

17/1358 (Other Identifier)

2016-004117-27 (EudraCT Number)

GRS1855/A/18 (Other Grant/Funding Number)

QUEPRO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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.
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Interventional

Experimental group

Description:

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

Treatment:

Drug: Quetiapine 25 milligrams capsule

control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule