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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Compare the incidence of postoperative delirium.
Compare the incidence of postoperative delirium.
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
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.
Time frame: 28 (± 2) days from the start of treatment in each patient.
Days without delirium, if it appears.
Number of days from the start of treatment until delirium.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
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Measurement of corrected QT interval (QTc) prolongation.
Increased (msec) ECG control.
Time frame: 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).
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Days in hospital from surgery.
Number of days from surgery until discharge.
Time frame: 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).
Time frame: 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.
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.