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

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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Quetiapine 25 milligrams capsule; Drug: Placebo oral capsule

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days	Drug: Quetiapine 25 milligrams capsule; Compare the incidence of postoperative delirium.; Other Names: Experimental arm
Placebo Comparator: control; Placebo 1 hour after surgery and each 12 hours for 3 days	Drug: Placebo oral capsule; Compare the incidence of postoperative delirium.; Other Names: Control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Collaborators: Instituto de Investigación Biomédica de Salamanca; Grupo Español de Rehabilitación Multimodal
• Investigators: Principal Investigator: Elisa Sanchez-Barrado, MD, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prophylaxis; Postoperative; Delirium; Quetiapine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antipsychotic Agents; Quetiapine Fumarate
• Other Study ID Numbers: QUEPRO; GRS1855/A/18 (Other Grant/Funding Number: Gerencia Regional de Salud de Castilla y León-JCYL); 17/1358 (Other Identifier: IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA); 2016-004117-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No