Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Drug: Dexamethasone
* Other: control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone, POCD, psycological tests<br>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<br>* a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia<br>* Other names: The Dexamethasone and Index Bispectral;|
| Sham Comparator: Control, POCD, psycological tests<br>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<br>* General anesthesia, without additional interventions<br>* Other names: Index Bispectral and not received the Desamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score in neuropsycological tests. | 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. | 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Postoperative cognitive dysfunction, General Anesthesia, neuropsychological tests