- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01332812
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05403-000
- General Hospital of the University of São Paulo Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients over 60 years,
- 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:
- age less than 60 years,
- history of brain disease or dementia, other psychiatric disorders that affect cognition,
- lack of proficiency in Portuguese,
- use of corticosteroids or opioid preoperatively.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
Other Names:
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Sham Comparator: 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. |
General anesthesia, without additional interventions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score in neuropsycological tests.
Time Frame: 6 months.
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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.
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6 months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria José C Carmona, M.D., Faculty of Medicine of the University of Sao Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Postoperative Complications
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- Maria J.C. Carmona
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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