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Completed

NCT Number: NCT02049411

Ketamine and Changes of the Short Portable Mental Status Questionnaire

- 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-.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Mexico City, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Other names: Ketalin, Ketalar, Ketanest

physiological solution

Drug

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

Other names: Control, Placebo

Primary outcomes

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

    Time frame: Baseline, 2 hours after surgery

    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

  1. Change in Hemodynamic measures

    Time frame: Baseline, after Retrobulbar block , 90 minutes into surgery.

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

  2. Change in respiratory rate measures

    Time frame: Baseline, after Retrobulbar block , 90 minutes into surgery.

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

  3. Changes in oxygen saturation measures

    Time frame: Baseline, after Retrobulbar block , 90 minutes into surgery.

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

  4. Change in Ramsey Sedation Scale

    Time frame: Baseline, after retrobulbar block, 90 minutes into surgery

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

  5. Change on intraocular pressure measures

    Time frame: Baseline (previous Retrobulbar block), end of surgery.

    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.

  6. Analgesia

    Time frame: Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery.

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

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Collaborators

  • National Polytechnic Institute, Mexico

Registry information

Official study title

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

Acronym: SPMSQ-E

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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