Ketamine and Changes of the Short Portable Mental Status Questionnaire

NCT02049411 | Completed Phase 2

• 1 other identifier: R-2012-3601-56
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

• 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-.

Conditions

Postoperative Cognitive Dysfunction

Keywords

Ketamine; acute cognitive dysfunction; geriatric patients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in Hemodynamic measures

  Baseline, after Retrobulbar block , 90 minutes into surgery.

• Change in respiratory rate measures

  Baseline, after Retrobulbar block , 90 minutes into surgery.

• Changes in oxygen saturation measures

  Baseline, after Retrobulbar block , 90 minutes into surgery.

• Change in Ramsey Sedation Scale

  Baseline, after retrobulbar block, 90 minutes into surgery

• Change on intraocular pressure measures

  Baseline (previous Retrobulbar block), end of surgery.

Study Arms (2)

Ketamine group

EXPERIMENTAL

Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.

Drug: Ketamine; Drug: physiological solution

physiological solution

SHAM COMPARATOR

Control group: only physiological solution at 0.9% (250 ml) during 2 hours, intravenously.

Drug: physiological solution

Interventions

Ketamine DRUG

Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.

Also known as: Ketalin, Ketalar, Ketanest

Ketamine group

physiological solution DRUG

physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.

Also known as: Control, Placebo

Ketamine group; physiological solution

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Mexico City, Mexico City, 06720, Mexico

Location

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• Frey K, Sukhani R, Pawlowski J, Pappas AL, Mikat-Stevens M, Slogoff S. Propofol versus propofol-ketamine sedation for retrobulbar nerve block: comparison of sedation quality, intraocular pressure changes, and recovery profiles. Anesth Analg. 1999 Aug;89(2):317-21. doi: 10.1097/00000539-199908000-00013.

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MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Dulce M. Rascon, M.D

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Maria E. Ocharan, PhD.

  Instituto Politecnico Nacional

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology - Pain Clinical professor.

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

ME (1)