Ketamine and Changes of the Short Portable Mental Status Questionnaire

Study Overview
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Brief Summary
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- Cognitive changes are related to aging, affecting the performance of older patients in the solution of problems and the execution of tasks. 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: Anesthesia and surgery. The time elapsed after surgery. 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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Participants will be patients programmed for a vitrectomy or cataract surgery involving a retrobulbar block, to be carried out with a local anesthesia. - 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.

Official Title
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Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E) After Ketamine Administration on Ophthalmic Surgery in Geriatric Population.

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Drug: Ketamine
* Drug: physiological solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients be over 60 years and older. Intraocular pressure less than 20 millimeter of mercury. American Society of Anaesthesiologists (ASA) physical status classification, I-III. Exclusion Criteria: History of psychosis or schizophrenia. 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine group<br>Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously. | Drug: Ketamine<br>* Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.<br>* Other names: Ketanest;Drug: physiological solution<br>* physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.<br>* Other names: Placebo;|
| Sham Comparator: physiological solution<br>Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously. | Drug: physiological solution<br>* physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups | Patients were included in an analysis of mean change from preoperative to postoperative assessment of the number of items missed on the SPMSQ using analysis of covariance (ANCOVA) model which contained baseline status as covariate, and the treatment group as the effect of interest. | Baseline, 2 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemodynamic measures | Analysis of changes over time in hemodynamic parameters was done during the surgery | Baseline, after Retrobulbar block , 90 minutes into surgery. | 
| Change in respiratory rate measures | Analysis of changes over time in respiratory rate was done during the surgery with a general lineal model. | Baseline, after Retrobulbar block , 90 minutes into surgery. | 
| Changes in oxygen saturation measures | Analysis of changes over time in oxygen saturation measures was done during the surgery with a general lineal model | Baseline, after Retrobulbar block , 90 minutes into surgery. | 
| Change in Ramsey Sedation Scale | Sedation according to the Ramsey Scale from baseline to the final assessment (90minutes into surgery), was done with a general lineal model. | Baseline, after retrobulbar block, 90 minutes into surgery | 
| Change on intraocular pressure measures | Analysis of change in intraocular pressure over time was done previous retrobulbar block and at the end of surgery with a general lineal model over non-surgical eye. | Baseline (previous Retrobulbar block), end of surgery. | 
| Analgesia | Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (χ2). | Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, acute cognitive dysfunction, geriatric patients