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| Name | Class |
|---|---|
| National Polytechnic Institute, Mexico | OTHER |
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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:
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-.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine group | Experimental | Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously. |
|
| physiological solution | Sham Comparator | Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dulce M. Rascon, M.D | Instituto Mexicano del Seguro Social | Principal Investigator |
| Maria E. Ocharan, PhD. | Instituto Politecnico Nacional | Study Director |
| Ana Fresan, PhD. | Instituto Nacional de Psiquiatria | Study Chair |
| Jorge H. Genis, Geriatrician | Instituto Mexicano del Seguro Social | Study Chair |
| Antonio Castellanos, M.D. | Instituto Mexicano del Seguro Social | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades | Mexico City | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7633725 | Background | Tolep K, Higgins N, Muza S, Criner G, Kelsen SG. Comparison of diaphragm strength between healthy adult elderly and young men. Am J Respir Crit Care Med. 1995 Aug;152(2):677-82. doi: 10.1164/ajrccm.152.2.7633725. | |
| 16738066 | Background | Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2. |
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| physiological solution | Drug | physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine. |
|
|
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. |
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|
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| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |