Clinical trial NCT03739476: Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
Official title: Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Delirium
Keywords: Postoperative
Delirium
Quetiapine
Prophylaxis
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
name: Grupo Español de Rehabilitación Multimodal
First posted: 2018-11-13
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one arm treatment. one arm placebo.
Primary purpose: TREATMENT

Brief 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 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: 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).

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Days without delirium, if it appears.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Duration of delirium, if it appears.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Severity of delirium measured with a validated scale. time of appearance the duration and severity. use of another antipsychotics.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Dose of other antipsychotic (haloperidol).
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Degree of sedation.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Measurement of corrected QT interval (QTc) prolongation.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Evaluation of extrapyramidal symptoms.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Days in hospital from surgery.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Perceived general well-being.
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
measure: Mortality (all causes)
timeFrame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
Study officials:
affiliation: Investigator
name: Elisa Sanchez-Barrado, MD
role: PRINCIPAL_INVESTIGATOR
References: