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

NCT03739476 | Terminated Phase 3

• 4 other identifiers: QUEPROGRS1855/A/1817/13582016-004117-27
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

Postoperative; Delirium; Quetiapine; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Days without delirium, if it appears.

  28 ± 2 days from the start (first dose) of treatment with quetiapine.

• Duration of delirium, if it appears.

  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.

  28 ± 2 days from the start (first dose) of treatment with quetiapine.

• Dose of other antipsychotic (haloperidol).

  28 ± 2 days from the start (first dose) of treatment with quetiapine.

• Degree of sedation.

  28 ± 2 days from the start (first dose) of treatment with quetiapine.

Study Arms (2)

Interventional

EXPERIMENTAL

Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days

Drug: Quetiapine 25 milligrams capsule

control

PLACEBO COMPARATOR

Placebo 1 hour after surgery and each 12 hours for 3 days

Drug: Placebo oral capsule

Interventions

Quetiapine 25 milligrams capsule DRUG

Compare the incidence of postoperative delirium.

Also known as: Experimental arm

Interventional

Placebo oral capsule DRUG

Compare the incidence of postoperative delirium.

Also known as: Control arm

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Grupo Español de Rehabilitación Multimodal: collaborator

Study Sites (1)

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elisa Sanchez-Barrado, MD

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one arm treatment. one arm placebo.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: November 13, 2018
• Study Start: February 13, 2019
• Primary Completion: April 2, 2020
• Study Completion: June 30, 2020
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)