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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

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—.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Drug: Ketamine Drug: physiological solution Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E) After Ketamine Administration on Ophthalmic Surgery in Geriatric Population.
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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:
  • 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

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:
  • Control
  • Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049411


Locations
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Mexico
Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
Mexico, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
National Polytechnic Institute, Mexico
Investigators
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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

Publications of Results:
Loots H, Wiseman R. Ophthalmic anaesthesia, agents for sedation in ophthalmic surgery: A review of the pharmacodynamics and clinical applications. Current Anaesthesia& Critical Care (2006) 17, 179-190
Moorthy SS, Valluri S, editors. Retrobulbar anesthesia—letters to the editor. Ophthalmology 2002;109(1):4-8.

Other Publications:
Gonzalez Montalvo J I; Rodriguez L; Ruiperez I. Validacion del cuestionario de Pfeiffer y la escala de incapacidad mental de la cruz roja en la deteccion del deterioro mental en los pacientes externos de un servicio de Geriatria. Revista Española de Geriatría y Gerontología. 1991, 27 (3): 129-133.
Attix Deborah K, Welsh-Bohmer Kathleen A: Geriatric Neuropsychology: assessment and intervention. Guilford Press, 2006.

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Responsible Party: Dulce Maria Rascon Martinez, Anesthesiology - Pain Clinical professor., Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02049411     History of Changes
Other Study ID Numbers: R-2012-3601-56
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social:
Ketamine
acute cognitive dysfunction
geriatric patients

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pharmaceutical Solutions
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action