Postoperative DeliriumPhase 3NCT03739476
Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
A Phase 3 study testing Quetiapine 25 milligrams capsule in people with Postoperative Delirium, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Quetiapine 25 milligrams capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2019to 30 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Delirium
- Being tested
- Quetiapine 25 milligrams capsule, Placebo oral capsule
- Keywords
- Postoperative, Delirium, Quetiapine, Prophylaxis
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine 25 milligrams capsuleDrug
Also called Experimental arm
Compare the incidence of postoperative delirium.
Placebo oral capsuleDrug
Also called Control arm
Compare the incidence of postoperative delirium.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days Receives: Drug: Quetiapine 25 milligrams capsule |
| control | Placebo comparator | Placebo 1 hour after surgery and each 12 hours for 3 days Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 (± 2) days from the start of treatment in each patient.
Secondary outcomes (10)
Days without delirium, if it appears.
Number of days from the start of treatment until delirium.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Measurement of corrected QT interval (QTc) prolongation.
Increased (msec) ECG control.
Measured: 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).
Measured: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Days in hospital from surgery.
Number of days from surgery until discharge.
Measured: 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).
Measured: 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.
Measured: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start13 Feb 2019
- Primary completion2 Apr 2020
- Study completion30 Jun 2020
Why it stopped: Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one arm treatment. one arm placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Grupo Español de Rehabilitación Multimodal
- Responsible party
- Sponsor
- Investigators
- Elisa Sanchez-Barrado, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739476
- Sponsor's protocol ID
- QUEPRO
- Other IDs
- GRS1855/A/18, 17/1358, 2016-004117-27, 2016
- Status last verified
- May 2025
- First submitted
- 18 Oct 2018
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine
- ClinicalTrials.gov ID
- NCT03739476
- Acronym / sponsor ID
- QUEPRO
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative, Delirium, Quetiapine, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Grupo Español de Rehabilitación Multimodal
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- one arm treatment. one arm placebo.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: Quetiapine 25 milligrams capsuleQuetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days |
| control | Placebo comparator | Drug: Placebo oral capsulePlacebo 1 hour after surgery and each 12 hours for 3 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine 25 milligrams capsuleAlso: Experimental armCompare the incidence of postoperative delirium. | Drug | Interventional |
| Placebo oral capsuleAlso: Control armCompare the incidence of postoperative delirium. | Drug | control |
Primary outcome
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.
10 secondary outcomes
Days without delirium, if it appears.
Time frame: 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.
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.
Dose of other antipsychotic (haloperidol).
Time frame: 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.
Measurement of corrected QT interval (QTc) prolongation.
Time frame: 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.
Days in hospital from surgery.
Time frame: 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.
Mortality (all causes)
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Results and safety
The study was stopped early (reason given: Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Sanchez-Barrado, MD principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine 25 milligrams capsule in people with Postoperative Delirium, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.