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

November 23, 2014 updated by: Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social

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

- 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-.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine group
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Drug: Ketamine
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Other Names:
  • Ketalar
  • Ketalin
  • Ketanest
Drug: physiological solution
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
Other Names:
  • Placebo
  • Control
Sham Comparator: physiological solution
Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Drug: physiological solution
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
Other Names:
  • Placebo
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, after Retrobulbar block , 90 minutes into surgery.
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.
Baseline, after Retrobulbar block , 90 minutes into surgery.
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
Baseline, after Retrobulbar block , 90 minutes into surgery.
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.
Baseline, after retrobulbar block, 90 minutes into surgery
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.
Baseline (previous Retrobulbar block), end of surgery.
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).
Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Collaborators

National Polytechnic Institute, Mexico

Investigators

  • Principal Investigator: Dulce M. Rascon, M.D, Instituto Mexicano del Seguro Social
  • Study Director: Maria E. Ocharan, PhD., Instituto Politecnico Nacional
  • Study Chair: Ana Fresan, PhD., Instituto Nacional de Psiquiatría
  • Study Chair: Jorge H. Genis, Geriatrician, Instituto Mexicano del Seguro Social
  • Study Chair: Antonio Castellanos, M.D., Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 23, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2012-3601-56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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