Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 450 for:    QUETIAPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739476
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborators:
Instituto de Investigación Biomédica de Salamanca
Grupo Español de Rehabilitación Multimodal
Information provided by (Responsible Party):
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Drug: Quetiapine 25 milligrams capsule Drug: Placebo oral capsule Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: one arm treatment. one arm placebo.
Masking: Double (Participant, Investigator)
Masking Description: double blinded.
Primary Purpose: Treatment
Official Title: Controlled, Double-blind, Randomized Clinical Trial for Prophilaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Interventional
Quetiapine 25 miligrames 1 hour after surgery and each 12 hours for 3 days
Drug: Quetiapine 25 milligrams capsule
Compare the incidence of postoperator delirium.

Placebo Comparator: control
Placebo 1 hour after surgery and each 12 hours for 3 days
Drug: Placebo oral capsule
Compare the incidence of postoperator delirium.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Days without delirium, if it appears. [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Number of days from the start of treatment until delirium.

  2. 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).


  3. 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 quetiapin. ]
    Severity of delirium measured with a the Delirium Rating Scale-Revised-98 (DRS-R-98).

  4. Dose of other antipsychotic (haloperidol). [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Total dose (mg) of other antipsychotic to control symptoms of delirium.

  5. Degree of sedation. [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Degree of sedation measured with a validated scale Richmond Agitation-Sedation Scale (RASS).

  6. Measurement of QTc prolongation. [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Increased (msec) ECG control.

  7. Evaluation of extrapyramidal symptoms. [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Presence o absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity).

  8. Days in hospital from surgery. [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Number of days from surgery until discharge.

  9. Perceived general well-being. [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Evaluation of quality of life using Short Form-36 Health Survey questionnaire (SF36).

  10. Mortality (all causes) [ Time Frame: 28 ± 2 days from the start (first dose) of treatment with quetiapin. ]
    Mortality at discharge and at 28 (± 2) days before the start of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 7 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 mg (milligrms) / dL (decilitre): 1 point

Exclusion Criteria:

  • Allergy to quetiapine.
  • Patients at low risk of developing delirium at admission.
  • Diagnosis of delirium at admission.
  • Cardiological diseases: qtc ≥ 460 mseg (millisecond) in men, ≥ 470 msec (millisecond) in women, recent MI or cardiac decompensation, 2-3 ° AV block or history of torsades de pointes arrhythmias or ventricular arrhythmias, bradycardia...
  • Hypokalemia ≤ 3 mEq / CLK.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739476


Contacts
Layout table for location contacts
Contact: Elisa Sanchez-Barrado, MD +34 923 291100 ext 55177 mesanchezba@saludcastillayleon.es
Contact: Carmen Arias, PhD +34 923210960 ensayosclinicos@ibsal.es

Locations
Layout table for location information
Spain
Complejo Asistencial Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Elisa Sanchez Barrado, Md    +34 923 291100 ext 55177    mesanchezba@saludcastillayleon.es   
Contact: Carmen Arias, pHD    +34923210960    ensayosclinicos@ibsal.es   
Sponsors and Collaborators
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Instituto de Investigación Biomédica de Salamanca
Grupo Español de Rehabilitación Multimodal
Investigators
Layout table for investigator information
Principal Investigator: Elisa Sanchez-Barrado, MD Investigator

Layout table for additonal information
Responsible Party: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
ClinicalTrials.gov Identifier: NCT03739476     History of Changes
Other Study ID Numbers: QUEPRO
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León:
Postoperative
Delirium
Quetiapine
Prophylaxis
Additional relevant MeSH terms:
Layout table for MeSH terms
Quetiapine Fumarate
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs