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

• Status: Terminated
• Trial end date: 2020-12-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Collaborators: Grupo Español de Rehabilitación Multimodal; Instituto de Investigación Biomédica de Salamanca
• Treatments: Quetiapine Fumarate

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 mg (milligrms) / dL (decilitre): 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 mseg (millisecond) in men, ≥ 470 msec (millisecond) 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 (kilograms).