Postoperative delirium in high risk surgical patients.
Conditions
Interventions
Trade Name: Quetiapina NORMON 25 mg comprimidos recubiertos con peícula EFG
Pharmaceutical Form: Capsule
INN or Proposed INN: Quetiapine fumarate
Other descriptive name: QUETIAPINE FUMARATE
Concentra
Sponsors
IBSAL (Instituto de Investigación Biomédica de
Eligibility
Sex/Gender
All
Inclusion 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 7 on the scale Delphi: - Age: 70-79 years: 1 point; =80 years: 2 points - Physical activity: need for assistance, not self-sufficient: 1 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 mg / dL: 1 point Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: - Allergy to quetiapine. - Patients at low risk of developing delirium at admission. - Diagnosis of delirium at admission. - Cardiological diseases: qtc > 460mseg in men, > 470 msec in women, recent MI or cardiac decompensation, 2-3 ° AV block or history of torsades de pointes arrhythmias or ventricular arrhythmias, bradycardia... - Hypokalemia <3 mEq / CLK. - 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of days from the start of treatment until delirium, if it appears. - Duration of delirium, in days. - Severity of delirium measured with a validated scale (DRS-R-98). - Total dose (mg) of other antipsychotic (haloperidol) to control symptoms of delirium. - Security variables: degree sedation: by RASS scale. QTc prolongation: increased msec ECG control. presence or absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity). - Days in hospital from surgery. - Perceived quality of life (using validated questionnaire SF36) at 28 (± 2) days before the start of treatment - Mortality (all causes) at discharge and at 28 (± 2) days before the start of treatment.;Timepoint(s) of evaluation of this end point: 28 (± 2) days before the start of treatment in each patient. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.;Secondary Objective: - Evaluate the safety and tolerability of the medication applied. - Compare the efficacy of medication versus placebo in relation to: the length of hospital stay. perceived quality of life. mortality (all causes) at discharge and at 28 ± 2 days from the start (first dose) of treatment with quetiapine. - In case of posoperative delirium , know: time of appearance the duration and severity. total dose of treatment with other antipsychotics.;Primary end point(s): Proportion of patients diagnosed with delirium (number of cases of delirium / total number of patients) within the first four days in both arms.;Timepoint(s) of evaluation of this end point: 28 (± 2) days before the start of treatment in each patient. | — |
Countries
Spain
Contacts
Public Contactunidad de ensayos clínicos
IBSAL
Outcome results
None listed