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Ketamine and Changes of the Short Portable Mental Status Questionnaire

Information source: Instituto Mexicano del Seguro Social
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Cognitive Dysfunction

Intervention: Ketamine (Drug); physiological solution (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Instituto Mexicano del Seguro Social

Official(s) and/or principal investigator(s):
Dulce M. Rascon, M.D, Principal Investigator, Affiliation: Instituto Mexicano del Seguro Social
Maria E. Ocharan, PhD., Study Director, Affiliation: Instituto Politecnico Nacional
Ana Fresan, PhD., Study Chair, Affiliation: Instituto Nacional de Psiquiatria
Jorge H. Genis, Geriatrician, Study Chair, Affiliation: Instituto Mexicano del Seguro Social
Antonio Castellanos, M.D., Study Chair, Affiliation: Instituto Mexicano del Seguro Social


- 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: 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—.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups

Secondary outcome:

Change in Hemodynamic measures

Change in respiratory rate measures

Changes in oxygen saturation measures

Change in Ramsey Sedation Scale

Change on intraocular pressure measures


Detailed description: 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.


Minimum age: 60 Years. Maximum age: 85 Years. Gender(s): Both.


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.

Locations and Contacts

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades, Mexico, Distrito Federal 06720, Mexico
Additional Information

Related publications:

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.

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.

Jones MJ, Piggott SE, Vaughan RS, Bayer AJ, Newcombe RG, Twining TC, Pathy J, Rosen M. Cognitive and functional competence after anaesthesia in patients aged over 60: controlled trial of general and regional anaesthesia for elective hip or knee replacement. BMJ. 1990 Jun 30;300(6741):1683-7.

Tsai TL, Sands LP, Leung JM. An Update on Postoperative Cognitive Dysfunction. Adv Anesth. 2010;28(1):269-284.

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Hudetz JA, Pagel PS. Neuroprotection by ketamine: a review of the experimental and clinical evidence. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):131-42. doi: 10.1053/j.jvca.2009.05.008. Epub 2009 Jul 29. Review.

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Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41.

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Attix Deborah K, Welsh-Bohmer Kathleen A: Geriatric Neuropsychology: assessment and intervention. Guilford Press, 2006.

Starting date: June 2013
Last updated: November 23, 2014

Page last updated: August 23, 2015

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