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

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (Other)

Overall Status

Terminated

CT.gov ID

NCT03739476

Collaborator

Instituto de Investigación Biomédica de Salamanca (Other), Grupo Español de Rehabilitación Multimodal (Other)

Enrollment

Location

Arms

16.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium	Drug: Quetiapine 25 milligrams capsule Drug: Placebo oral capsule	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

one arm treatment. one arm placebo.one arm treatment. one arm placebo.

Masking:

Double (Participant, Investigator)

Masking Description:

double blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 13, 2019

Actual Primary Completion Date :

Apr 2, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days	Drug: Quetiapine 25 milligrams capsule Compare the incidence of postoperative delirium. Other Names: Experimental arm
Placebo Comparator: control Placebo 1 hour after surgery and each 12 hours for 3 days	Drug: Placebo oral capsule Compare the incidence of postoperative delirium. Other Names: Control arm

Arm

Intervention/Treatment

Experimental: Interventional

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

Drug: Quetiapine 25 milligrams capsule

Compare the incidence of postoperative delirium.

Other Names:

Experimental arm

Placebo Comparator: control

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

Drug: Placebo oral capsule

Compare the incidence of postoperative delirium.

Other Names:

Control arm

Outcome Measures

Primary Outcome Measures

To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo. [28 (± 2) days from the start of treatment in each patient.]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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: 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).