Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.

Study Overview
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Brief Summary
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the prevalence of depression in elderly is from 4 to 30% and is associated with a lower quality of life mayor medical comorbidity, and increased mortality. Although there are various treatments for depression in the elderly, the study of interventions in resistant depression is limited and there are few reports of the efficacy and safety profile of alternative interventions such as ketamine in the elderly. The final objective of the present study is to report the effects of a single infusion of ketamine on the depressive symptoms in patients undergoing ophthalmologic surgery

Detailed Description
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The final objective of the present study is to report the effects of a single infusion of 0.5 mg / kg ketamine in infusion on depressive symptoms assessed using the scale Yesavage's abbreviated Geriatric Depression Scale. This is a randomized double-blind follow-up study in patients over 60 years of age with ocular pathology who required ophthalmological surgery with retrobulbar block and conscious sedation with ketamine. The sample consisted of two groups: a control group and an experimental group with ketamine. The dose used for the study was 0.5mg / kg in slow infusion for two hours. In both groups the Yesavage's questionnaire was applied at three different times; Basally, at the end of the recovery and at 24 hours after the surgery.

Official Title
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A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.

Conditions
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Depression in Old Age, Ketamine

Intervention / Treatment
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* Drug: Ketamine
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 60 years or older who due to the severity of visual disability required to be operated on for eye surgery using retrobulbar block Intraocular pressure <20 mm Hg and ASA functional capacity from I to III Exclusion Criteria: Previous antidepressants medications Cognitive impairment was found according to the Short Portable Mental Status Questionnaire (SPMSQ) assessment In case of a history of psychosis, schizophrenia, nephropathy They had a history of difficulties to control arterial blood pressure, uncontrolled hepatic disorders or had a history of adverse response to ketamine according clinical records

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, dose-controlled follow-up study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine<br>single infusion of 0.5 mg / kg ketamine | Drug: Ketamine<br>* single infusion of 0.5 mg / kg ketamine<br>|
| Sham Comparator: control<br>physiological solution at 0.9 % with the same physical characteristics of ketamine solution, | Other: control<br>* physiological solution at 0.9 % with the same physical characteristics of ketamine solution,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Change in the total score in a scale for Geriatric Depression the Geriatric Depression Scale.  It will be consider as an outcome the total score. The scale have a maximun score of 15 and minimum of 0. Higher values are considered a worse outcome. | two hours and 24 hours after the ketamine infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression rate | change in the percentage of patients with criteria for depression based on cutting point of 5 scale | two hours and 24 hours after the ketamine infusion |