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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: Quetiapine 25 milligrams capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one arm treatment. one arm placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days | Drug: Quetiapine 25 milligrams capsule<br>* Compare the incidence of postoperative delirium.<br>* Other names: Experimental arm;|
| Placebo Comparator: control<br>Placebo 1 hour after surgery and each 12 hours for 3 days | Drug: Placebo oral capsule<br>* Compare the incidence of postoperative delirium.<br>* Other names: Control arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo. | Proportion of patients diagnosed with delirium (number of cases of delirium / total number of patients) within the first four days in both arms. 65 years, treated early with prophylactic quetiapine versus placebo. | 28 (± 2) days from the start of treatment in each patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days without delirium, if it appears. | Number of days from the start of treatment until delirium. | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Duration of delirium, if it appears. | Number of days with delirium, if it appears. Perceived quality of life. Mortality (all causes). | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Severity of delirium measured with a validated scale. time of appearance the duration and severity. use of another antipsychotics. | Severity of delirium measured with a the Delirium Rating Scale-Revised-98 (DRS-R-98). | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Dose of other antipsychotic (haloperidol). | Total dose (mg) of other antipsychotic to control symptoms of delirium. | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Degree of sedation. | Degree of sedation measured with a validated scale Richmond Agitation-Sedation Scale (RASS). | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Measurement of corrected QT interval (QTc) prolongation. | Increased (msec) ECG control. | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Evaluation of extrapyramidal symptoms. | Presence o absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity). | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Days in hospital from surgery. | Number of days from surgery until discharge. | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Perceived general well-being. | Evaluation of quality of life using Short Form-36 Health Survey questionnaire (SF36). | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 
| Mortality (all causes) | Mortality at discharge and at 28 (± 2) days before the start of treatment. | 28 ± 2 days from the start (first dose) of treatment with quetiapine. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quetiapine, Prophylaxis, Postoperative, Delirium