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

Phase 3

Terminated

• Conditions: Postoperative Delirium
• Interventions: Drug: Quetiapine 25 milligrams capsule; Drug: Placebo oral capsule

• Registration Number: NCT03739476
• Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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.

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 Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Study Start: 2019-02-13
• Primary Completion: 2020-04-02
• Study Completion: 2020-06-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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: corrected QT interval (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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Quetiapine 25 milligrams capsule	Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days
control	Placebo oral capsule	Placebo 1 hour after surgery and each 12 hours for 3 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).
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.
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.
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.

Trial Locations

Locations (1)

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Spain