Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
NCT ID: NCT01332812
Last Updated: 2015-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2011-01-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dexamethasone and Postoperative Delirium
NCT02109081
The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery
NCT02123355
Depth of Anaesthesia and Cognitive Dysfunction
NCT00719628
Cognitive Dysfunction Following Cardiac Surgery
NCT02767713
The Neuroprotective Effect of Dexmedetomidine Preserving Brain Functional Connectivity in Elderly Patients
NCT04973124
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexamethasone, POCD, psycological tests
Subjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered.
Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.
Dexamethasone
a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
Control, POCD, psycological tests
Subjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered.
Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.
control group
General anesthesia, without additional interventions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone
a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
control group
General anesthesia, without additional interventions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* underwent surgery for inguinal hernia repair, Nissen procedure, cholecystectomy or other surgeries midsize under general anesthesia and hospital stay expected within 72 hours.
Exclusion Criteria
* history of brain disease or dementia, other psychiatric disorders that affect cognition,
* lack of proficiency in Portuguese,
* use of corticosteroids or opioid preoperatively.
60 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Duke University
OTHER
University of Sao Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maria José Carvalho Carmona
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria José C Carmona, M.D.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine of the University of Sao Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
General Hospital of the University of São Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Valentin LS, Pereira VF, Pietrobon RS, Schmidt AP, Oses JP, Portela LV, Souza DO, Vissoci JR, Luz VF, Trintoni LM, Nielsen KC, Carmona MJ. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction-A Phase III Double Blind, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0152308. doi: 10.1371/journal.pone.0152308. eCollection 2016.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Maria J.C. Carmona
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.