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

May 21, 2025 updated by: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
28 (± 2) days from the start of treatment in each patient.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days without delirium, if it appears.
Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
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.
Time Frame: 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).
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.
Time Frame: 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).
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Dose of other antipsychotic (haloperidol).
Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
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.
Time Frame: 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).
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Measurement of corrected QT interval (QTc) prolongation.
Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Increased (msec) ECG control.
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Evaluation of extrapyramidal symptoms.
Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
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.
Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Number of days from surgery until discharge.
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Perceived general well-being.
Time Frame: 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).
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Mortality (all causes)
Time Frame: 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.
28 ± 2 days from the start (first dose) of treatment with quetiapine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Investigación Biomédica de Salamanca
Grupo Español de Rehabilitación Multimodal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisa Sanchez-Barrado, MD, Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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