Ketamine and Changes of the Short Portable Mental Status Questionnaire

Ketamine

Brief Summary

- 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-.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
  • physiological solution (DRUG)
    physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.

Condition or Disease

  • Postoperative Cognitive Dysfunction

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 60 Years to 85 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2013
    Primary Completion: Jan 01, 2014 ACTUAL
    Completion Date: May 01, 2014 ACTUAL
    Study First Posted: Jan 30, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 23, 2014

    Sponsors / Collaborators

    Lead Sponsor: Instituto Mexicano del Seguro Social
    Responsible Party: N/A

    Location

    Distrito Federal, Mexico
    Mexico, Distrito Federal, Mexico

    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.

    Participant Groups

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 60
    Maximum Age: 85
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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.

    Secondary Outcomes

    • Analysis of changes over time in hemodynamic parameters was done during the surgery

    • Analysis of changes over time in respiratory rate was done during the surgery with a general lineal model.

    • Analysis of changes over time in oxygen saturation measures was done during the surgery with a general lineal model

    • Sedation according to the Ramsey Scale from baseline to the final assessment (90minutes into surgery), was done with a general lineal model.

    • 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.

    • Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (χ2).

    More Details

    NCT Number: NCT02049411
    Acronym: SPMSQ-E
    Other IDs: R-2012-3601-56
    Study URL: https://clinicaltrials.gov/study/NCT02049411
    Last updated: Sep 29, 2023