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

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Ketamine
physiological solution
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Cognitive Dysfunction focused on measuring Ketamine, acute cognitive dysfunction, geriatric patients

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ketamine group

physiological solution

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Change in Hemodynamic measures
Analysis of changes over time in hemodynamic parameters was done during the surgery
Change in respiratory rate measures
Analysis of changes over time in respiratory rate was done during the surgery with a general lineal model.
Changes in oxygen saturation measures
Analysis of changes over time in oxygen saturation measures was done during the surgery with a general lineal model
Change in Ramsey Sedation Scale
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
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
Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (χ2).

Full Information

First Posted
January 27, 2014
Last Updated
November 23, 2014
Sponsor
Instituto Mexicano del Seguro Social
Collaborators
National Polytechnic Institute, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02049411
Brief Title
Ketamine and Changes of the Short Portable Mental Status Questionnaire
Acronym
SPMSQ-E
Official Title
Changes of the Short Portable Mental Status Questionnaire (SPMSQ-E) After Ketamine Administration on Ophthalmic Surgery in Geriatric Population.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
Collaborators
National Polytechnic Institute, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Anesthesia and surgery. The time elapsed after surgery. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Ketamine, acute cognitive dysfunction, geriatric patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine group
Arm Type
Experimental
Arm Description
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Arm Title
physiological solution
Arm Type
Sham Comparator
Arm Description
Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalin, Ketalar, Ketanest
Intervention Description
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
Intervention Type
Drug
Intervention Name(s)
physiological solution
Other Intervention Name(s)
Control, Placebo
Intervention Description
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
Primary Outcome Measure Information:
Title
Change from baseline to postoperative endpoint error scores on the Short Portable Mental Status Questionnaire (SPMSQ) in both groups
Description
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.
Time Frame
Baseline, 2 hours after surgery
Secondary Outcome Measure Information:
Title
Change in Hemodynamic measures
Description
Analysis of changes over time in hemodynamic parameters was done during the surgery
Time Frame
Baseline, after Retrobulbar block , 90 minutes into surgery.
Title
Change in respiratory rate measures
Description
Analysis of changes over time in respiratory rate was done during the surgery with a general lineal model.
Time Frame
Baseline, after Retrobulbar block , 90 minutes into surgery.
Title
Changes in oxygen saturation measures
Description
Analysis of changes over time in oxygen saturation measures was done during the surgery with a general lineal model
Time Frame
Baseline, after Retrobulbar block , 90 minutes into surgery.
Title
Change in Ramsey Sedation Scale
Description
Sedation according to the Ramsey Scale from baseline to the final assessment (90minutes into surgery), was done with a general lineal model.
Time Frame
Baseline, after retrobulbar block, 90 minutes into surgery
Title
Change on intraocular pressure measures
Description
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.
Time Frame
Baseline (previous Retrobulbar block), end of surgery.
Title
Analgesia
Description
Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (χ2).
Time Frame
Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dulce M. Rascon, M.D
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria E. Ocharan, PhD.
Organizational Affiliation
Instituto Politecnico Nacional
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Fresan, PhD.
Organizational Affiliation
Instituto Nacional de Psiquiatria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jorge H. Genis, Geriatrician
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonio Castellanos, M.D.
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

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Ketamine and Changes of the Short Portable Mental Status Questionnaire

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