Trial | NCT02049411  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
- 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-.
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.
Study Started
Jun 30
2013
Primary Completion
Jan 31
2014
Study Completion
May 31
2014
Last Update
Nov 25
2014
Estimate

Drug Ketamine

Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.

  • Other names: Ketalin, Ketalar, Ketanest

Drug physiological solution

physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.

  • Other names: Control, Placebo

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.

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.
No Results Posted