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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2018-07-30

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

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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.

Conditions

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Depression in Old Age Ketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, dose-controlled follow-up study

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketamine

single infusion of 0.5 mg / kg ketamine

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

single infusion of 0.5 mg / kg ketamine

control

physiological solution at 0.9 % with the same physical characteristics of ketamine solution,

Group Type SHAM_COMPARATOR

control

Intervention Type OTHER

physiological solution at 0.9 % with the same physical characteristics of ketamine solution,

Interventions

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Ketamine

single infusion of 0.5 mg / kg ketamine

Intervention Type DRUG

control

physiological solution at 0.9 % with the same physical characteristics of ketamine solution,

Intervention Type OTHER

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes