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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03739476
• Other study ID #: QUEPRO
• Secondary ID: GRS1855/A/1817/1
• Status: Terminated
• Phase: Phase 3
• Start date: February 13, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2022
• Source: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• Quetiapine 25 milligrams capsule
Compare the incidence of postoperative delirium.
• Placebo oral capsule
Compare the incidence of postoperative delirium.

Locations

Country	Name	City	State
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León	Grupo Español de Rehabilitación Multimodal, Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Measurement of corrected QT interval (QTc) prolongation.	Increased (msec) ECG control.	28 ± 2 days from the start (first dose) of treatment with quetiapine.
Secondary	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.
Secondary	Days in hospital from surgery.	Number of days from surgery until discharge.	28 ± 2 days from the start (first dose) of treatment with quetiapine.
Secondary	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.
Secondary	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.