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

Not Applicable

Completed

• Conditions: Depression in Old Age; Ketamine
• Interventions: Drug: Ketamine; Other: control

• Registration Number: NCT03473431
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Study Start: 2018-04-15
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine	Ketamine	single infusion of 0.5 mg / kg ketamine
control	control	physiological solution at 0.9 % with the same physical characteristics of ketamine solution,

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	two hours and 24 hours after the ketamine infusion	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.

Secondary Outcome Measures

Name	Time	Method
Depression rate	two hours and 24 hours after the ketamine infusion	change in the percentage of patients with criteria for depression based on cutting point of 5 scale

Trial Locations

Locations (1)

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades; 🇲🇽 Mexico City, Cdmx, Mexico