A Phase 3 interventional study of Quetiapine 25 milligrams capsule and Placebo oral capsule in Postoperative Delirium, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Terminated at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Phase 3, Interventional, and Treatment
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.
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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's enrollment of 54 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days
Drug: Quetiapine 25 milligrams capsule
Placebo 1 hour after surgery and each 12 hours for 3 days
Drug: Placebo oral capsule
Compare the incidence of postoperative delirium.
Also known as: Experimental arm
Compare the incidence of postoperative delirium.
Also known as: Control arm
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.
Time frame: 28 (± 2) days from the start of treatment in each patient.
Days without delirium, if it appears.
Number of days from the start of treatment until delirium.
Time frame: 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).
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.
Severity of delirium measured with a the Delirium Rating Scale-Revised-98 (DRS-R-98).
Time frame: 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.
Time frame: 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).
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Measurement of corrected QT interval (QTc) prolongation.
Increased (msec) ECG control.
Time frame: 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).
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
Days in hospital from surgery.
Number of days from surgery until discharge.
Time frame: 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).
Time frame: 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.
Time frame: 28 ± 2 days from the start (first dose) of treatment with quetiapine.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León