Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
| Grupo Español de Rehabilitación Multimodal | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days |
|
| control | Placebo Comparator | Placebo 1 hour after surgery and each 12 hours for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine 25 milligrams capsule | Drug | Compare the incidence of postoperative delirium. |
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elisa Sanchez-Barrado, MD | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Asistencial Universitario de Salamanca | Salamanca | 37007 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2019 | Oct 24, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2019 | Oct 24, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
one arm treatment. one arm placebo.
Not provided
Not provided
double blinded.
| Placebo oral capsule | Drug | Compare the incidence of postoperative delirium. |
|
|
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. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |