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

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ClinicalTrials.gov Identifier: NCT02049411
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : November 25, 2014
Sponsor:
Collaborator:
National Polytechnic Institute, Mexico
Information provided by (Responsible Party):
Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social

Tracking Information
First Submitted Date  ICMJE January 27, 2014
First Posted Date  ICMJE January 30, 2014
Last Update Posted Date November 25, 2014
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02049411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Changes of the Short Portable Mental Status Questionnaire
Official Title  ICMJE Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E) After Ketamine Administration on Ophthalmic Surgery in Geriatric Population.
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—.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Postoperative Cognitive Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ketamine group
    Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
    Interventions:
    • Drug: Ketamine
    • Drug: physiological solution
  • Sham Comparator: physiological solution
    Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
    Intervention: Drug: physiological solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2014)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02049411
Other Study ID Numbers  ICMJE R-2012-3601-56
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social
Study Sponsor  ICMJE Instituto Mexicano del Seguro Social
Collaborators  ICMJE National Polytechnic Institute, Mexico
Investigators  ICMJE
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 Psiquiatria
Study Chair: Jorge H. Genis, Geriatrician Instituto Mexicano del Seguro Social
Study Chair: Antonio Castellanos, M.D. Instituto Mexicano del Seguro Social
PRS Account Instituto Mexicano del Seguro Social
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP