A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Depressive symptoms
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
ketamine
single infusion of 0.5 mg / kg ketamine
Intervention: Ketamine (Drug)
control
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Intervention: control (Other)
Outcomes
Primary Outcomes
Depressive symptoms
Time Frame: 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 Outcomes
- Depression rate(two hours and 24 hours after the ketamine infusion)
Investigators
Dulce Maria Rascon Martinez
Principal Investigator
Instituto Mexicano del Seguro Social