Ketamine and Changes of the Short Portable Mental Status Questionnaire

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—.

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

Analgesia

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.

Criteria:

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.

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

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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