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

I

Instituto Mexicano del Seguro Social

Status

Completed

Conditions

Ketamine
Depression in Old Age

Treatments

Other: control
Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03473431
IMexicanoSS

Details and patient eligibility

About

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

Full 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.

Enrollment

90 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups

ketamine
Experimental group
Description:
single infusion of 0.5 mg / kg ketamine
Treatment:
Drug: Ketamine
control
Sham Comparator group
Description:
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Treatment:
Other: control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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