Ketamine and Changes of the Short Portable Mental Status Questionnaire
NCT ID: NCT02049411
Last Updated: 2014-11-25
Study Results
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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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2013-06-30
2014-05-31
Brief Summary
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This phenomenon has been observed as a decline of neurophysiological domains, especially memory, and the velocity of thought.
* Anesthesia and surgery performed contributes to its development then, is named post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of:
1. Anesthesia and surgery.
2. The time elapsed after surgery.
3. The population studied, and the type of cognitive test employed.
* The aim of this study is to evaluate the changes around the Short Portable Mental Status Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on the common conditions of geriatric patients, -comorbid and settings as minor surgery-.
Detailed Description
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\- Administration of ketamine will be suspended during the study for any cause considered as a risk to the patient according to the judgment of the researchers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Ketamine group
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Ketamine
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
physiological solution
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
physiological solution
Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
physiological solution
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
Interventions
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Ketamine
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
physiological solution
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intraocular pressure less than 20 millimeter of mercury.
* American Society of Anaesthesiologists (ASA) physical status classification, I-III.
Exclusion Criteria
* Nephropathy.
* Difficult to control hypertension.
* Uncontrolled hepatic disorders.
* Allergy to ketamine.
* Moderate to severe depression.
* Post-operative delirium.
* Needed to use medications other than those contemplated in the study.
60 Years
85 Years
ALL
Yes
Sponsors
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National Polytechnic Institute, Mexico
OTHER
Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Dulce Maria Rascon Martinez
Anesthesiology - Pain Clinical professor.
Principal Investigators
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Dulce M. Rascon, M.D
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Maria E. Ocharan, PhD.
Role: STUDY_DIRECTOR
Instituto Politecnico Nacional
Ana Fresan, PhD.
Role: STUDY_CHAIR
Instituto Nacional de Psiquiatria
Jorge H. Genis, Geriatrician
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Antonio Castellanos, M.D.
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Locations
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Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
Mexico City, Mexico City, Mexico
Countries
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References
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Other Identifiers
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R-2012-3601-56
Identifier Type: -
Identifier Source: org_study_id