Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
Recruitment status was Recruiting
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Purpose
This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Cognitive Dysfunction |
Drug: Dexamethasone Other: control group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia |
- Score in neuropsycological tests. [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Drug: Dexamethasone
a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
|
|
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. |
Other: control group
General anesthesia, without additional interventions
|
Detailed Description:
Postoperative cognitive dysfunction is related with the use of opioids in the postoperative period, lack of physical activity, fatigue, postoperative pain and quality of life. The use of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Maria J.C. Carmona, M.D. | 55-11-3069-6335 | maria.carmona@incor.usp.br |
| Brazil | |
| General Hospital of the University of São Paulo Medical School | Recruiting |
| São Paulo, Brazil, 05403-000 | |
| Contact: Maria JC Carmona, Carmona 55-11-3069-6335 maria.carmona@incor.usp.br | |
| Contact: Lívia SS Valentin, Psy lssv@usp.com.br | |
| Sub-Investigator: Lívia SS Valentin, Psy | |
| Principal Investigator: Maria JC Carmona, MD | |
More Information
No publications provided
| Responsible Party: | Maria José Carvalho Carmona, PhD, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01332812 History of Changes |
| Other Study ID Numbers: | Maria J.C. Carmona |
| Study First Received: | April 7, 2011 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo:
|
Dexamethasone Postoperative cognitive dysfunction General Anesthesia neuropsychological tests |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Anesthetics Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013