Ketamine and Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E)

Instituto Mexicano del Seguro Social

Status and phase: Completed; Phase 2

Conditions: Postoperative Cognitive Dysfunction

Treatments: Drug: Ketamine; Drug: physiological solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02049411

R-2012-3601-56

Details and patient eligibility

About

• 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-.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Ketamine group

Experimental group

Description:

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

Treatment:

Drug: physiological solution

Drug: Ketamine

physiological solution

Sham Comparator group

Description:

Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.

Treatment:

Drug: physiological solution