Clinical trial NCT03473431: Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.
Official title: A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Old Age
Ketamine
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
First posted: 2018-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, dose-controlled follow-up study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: two hours and 24 hours after the ketamine infusion
Secondary outcomes:
measure: Depression rate
timeFrame: two hours and 24 hours after the ketamine infusion
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
state: Cdmx
Study officials:
affiliation: imss
name: DULCE RASCON MARTINEZ, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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