Status:
UNKNOWN
Ketamine vs Midazolam on Cognitive Function in Elderly in Elective Surgery Three-Months Postoperatively (ketaminvsMDZ)
Lead Sponsor:
Universidad de Colima
Collaborating Sponsors:
Instituto Mexicano del Seguro Social
Conditions:
Cognitive Dysfunction
Eligibility:
All Genders
60-85 years
Phase:
PHASE3
Brief Summary
Deterioration of posoperative cognitive function (DCPO) is an intermediate state between normal cognitive aging and dementia, defined as a cognitive alteration greater than expected for the patient's ...
Detailed Description
Randomized double blind clinical trial. Male and female patients 60-90 years of age scheduled in elective surgery under regional anesthesia and sedation. The researchers will be double blind and the ...
Eligibility Criteria
Inclusion
- age 60-90 years,
- complete primary,
- ASA I-II,
- scheduled for non-urgent surgery,
- to whom regional anesthesia and sedation are applied
- sign the informed consent
- Able to answer the brief examination of the mental state (MMSE ) preliminary with more than 24 points
Exclusion
- not able to respond to MMSE, deaf-mute, blindness,
- history of surgery the last 6 months,
- use of pacemakers,
- allergy to anesthetics,
- use of psychiatric medication, or drugs,
- diagnosed neurological disease (cerebrovascular disease, dementia, seizures) ,
- surgery scheduled for prostate resection, or reduction of hip fractures
Key Trial Info
Start Date :
January 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04134052
Start Date
January 24 2021
End Date
June 20 2021
Last Update
January 26 2021
Active Locations (1)
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1
Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez
Colima, Mexico, 28984