Back to resultsClinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
Primary Purpose
Postoperative Delirium
Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Quetiapine 25 milligrams capsule
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Delirium focused on measuring Postoperative, Delirium, Quetiapine, Prophylaxis
Eligibility Criteria
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: 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).
Sites / Locations
- Complejo Asistencial Universitario de Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interventional
control
Arm Description
Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days
Placebo 1 hour after surgery and each 12 hours for 3 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Days without delirium, if it appears.
Number of days from the start of treatment until delirium.
Duration of delirium, if it appears.
Number of days with delirium, if it appears. Perceived quality of life.
Mortality (all causes).
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).
Dose of other antipsychotic (haloperidol).
Total dose (mg) of other antipsychotic to control symptoms of delirium.
Degree of sedation.
Degree of sedation measured with a validated scale Richmond Agitation-Sedation Scale (RASS).
Measurement of corrected QT interval (QTc) prolongation.
Increased (msec) ECG control.
Evaluation of extrapyramidal symptoms.
Presence o absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity).
Days in hospital from surgery.
Number of days from surgery until discharge.
Perceived general well-being.
Evaluation of quality of life using Short Form-36 Health Survey questionnaire (SF36).
Mortality (all causes)
Mortality at discharge and at 28 (± 2) days before the start of treatment.
Full Information
NCT ID
NCT03739476
First Posted
October 18, 2018
Last Updated
June 10, 2022
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
1. Study Identification
Unique Protocol Identification Number
NCT03739476
Brief Title
Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
Official Title
Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
April 2, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Postoperative, Delirium, Quetiapine, Prophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
one arm treatment. one arm placebo.
Masking
ParticipantInvestigator
Masking Description
double blinded.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Quetiapine 25 milligrams 1 hour after surgery and each 12 hours for 3 days
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Placebo 1 hour after surgery and each 12 hours for 3 days
Intervention Type
Drug
Intervention Name(s)
Quetiapine 25 milligrams capsule
Other Intervention Name(s)
Experimental arm
Intervention Description
Compare the incidence of postoperative delirium.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Control arm
Intervention Description
Compare the incidence of postoperative delirium.
Primary Outcome Measure Information:
Title
To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.
Description
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.
Secondary Outcome Measure Information:
Title
Days without delirium, if it appears.
Description
Number of days from the start of treatment until delirium.
Time Frame
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Title
Duration of delirium, if it appears.
Description
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.
Title
Severity of delirium measured with a validated scale. time of appearance the duration and severity. use of another antipsychotics.
Description
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.
Title
Dose of other antipsychotic (haloperidol).
Description
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.
Title
Degree of sedation.
Description
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.
Title
Measurement of corrected QT interval (QTc) prolongation.
Description
Increased (msec) ECG control.
Time Frame
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Title
Evaluation of extrapyramidal symptoms.
Description
Presence o absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity).
Time Frame
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Title
Days in hospital from surgery.
Description
Number of days from surgery until discharge.
Time Frame
28 ± 2 days from the start (first dose) of treatment with quetiapine.
Title
Perceived general well-being.
Description
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.
Title
Mortality (all causes)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Sanchez-Barrado, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
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