Ketamine and Changes of the Short Portable Mental Status Questionnaire

Postoperative Cognitive Dysfunction Clinical Trial

— SPMSQ-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049411
• Other study ID #: R-2012-3601-56
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2014
• Last updated: November 23, 2014
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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—.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Ketamine
Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
• physiological solution
physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.

Locations

Country	Name	City	State
Mexico	Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades	Mexico	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social	National Polytechnic Institute, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 2 hours after surgery	Yes
Secondary	Change in Hemodynamic measures	Analysis of changes over time in hemodynamic parameters was done during the surgery	Baseline, after Retrobulbar block , 90 minutes into surgery.	Yes
Secondary	Change in respiratory rate measures	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.	Yes
Secondary	Changes in oxygen saturation measures	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.	Yes
Secondary	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.	Baseline, after retrobulbar block, 90 minutes into surgery	Yes
Secondary	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.	Baseline (previous Retrobulbar block), end of surgery.	Yes
Secondary	Analgesia	Analgesia was evaluated after regional anesthesia (retrobulbar block) and after surgery, a comparison was made between groups by the Chi-squared test (?2).	Changes in analgesia after regional anaesthesia (retrobulbar block). Changes in analgesia over 30 minutes after surgery.	Yes