Ketamine vs Midazolam on Cognitive Function in Elderly in Elective Surgery Three-Months Postoperatively (ketaminvsMDZ) (ketaminvsMDZ)

January 24, 2021 updated by: Pedro Julian Flores Moreno, Universidad de Colima

Effect of Regional Anesthesia and Sedation With Ketamine Versus Regional Anesthesia and Sedation With Midazolam in Cognitive Function in Patients Over 60 Years of Age in Elective Surgery at 3 Months of Postoperative Follow-up

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 age and educational level, but which doesn't interfere with the activities of daily life, in its evolution it can lead to dementia or it can present reversal of the deterioration with return to a normal cognitive state, or a stabilization with permanence in a state of moderate alteration. In general, higher cognitive function can be affected by organic or functional problems, anesthetic-surgical, diseases associated with the elderly and / or chronic-degenerative comorbidities. Older patients who undergo regional anesthesia have special interest, the adverse cardiovascular effects, or prolonged sedation due to a pharmacokinetics that is altered by age, call special attention to reduce complications in the postoperative period. In 2010 at the Siglo XXI Hospital in Mexico City, the 68-year-old population attended was 30% of those with postoperative cognitive dysfunction 26% a week, and 10% persistence at 3 months. The DSM V recommends a neuropsychiatric, psychological and cognitive evaluation of the patient in the postoperative period, through tests such as the Mini Mental State Examination. sub-anesthetic doses of ketamine have been recently proposed to reduce the postoperative markers of inflammation, pain and opioids, in addition to having an antidepressant effect. There is a pharmacological rationale for using ketamine as a preventative measure against postoperative delirium based on its N-methyl-D-aspartate (NMDA) antagonism, It has the potential to protect against such neurological injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 data analyzer will ignore the drug used ( it it should be midazolam or ketamine in an intravenous infusion). The principal investigator will limit himself to collecting the questionnaires and following up to 3 months. Simple finite randomization in two groups, will be done through envelopes.

The pre-surgical, post-surgical Mini Mental questionnaire will be applied on the first day, 1 month and 3 months. During the trans-anesthetic, hemodynamic variables and anesthetic depth index measurements will be taken, surgical time, estimated bleeding, use of other adjuvant medications, type of surgery and comorbidities will be taken as intervening variables.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: karina Espinoza-Mejia, Msc
  • Phone Number: 52-1 312-1164758
  • Email: kespinoza2@ucol.mx

Study Contact Backup

  • Name: Fabian Rojas-Larios, Phd
  • Phone Number: 52-1 312 1206804
  • Email: frojas@ucol.mx

Study Locations

  • Mexico
      • Colima, Mexico, 28984
        • Recruiting
        • Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez
        • Contact:
        • Contact:
          • Fabian Rojas-Larios, Phd
          • Phone Number: 52 1 312 12 06804
          • Email: frojas@ucol.mx
        • Sub-Investigator:
          • Jose Guzman-Esquivel, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketamine sedation
Sedation will be performed with ketamine dose 5-20mcg / kg / min in infusion with 100 ml Na Cl solution 0.9% during surgery
Drug: ketamine sedation versus midazolam sedation
Sedation with ketamine 5-20 mcg / kg / hr in infusion in 100ml Na Cl solution 0.9% during surgery and the second midazolam group 5 mcg- 35 mcg / kg / hr in infusion in 100ml Na Cl solution 0.9% will be administered during surgery
Other Names:
  • ketamine sedation
Active Comparator: midazolam sedation
Sedation will be performed with midazolam dose 5 - 35mcg / kg / hr in infusion with 100 ml Na Cl solution 0.9% during surgery
Drug: ketamine sedation versus midazolam sedation
Sedation with ketamine 5-20 mcg / kg / hr in infusion in 100ml Na Cl solution 0.9% during surgery and the second midazolam group 5 mcg- 35 mcg / kg / hr in infusion in 100ml Na Cl solution 0.9% will be administered during surgery
Other Names:
  • ketamine sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function at baseline
Time Frame: It takes 30 minutes before the preparation of the surgery
the mini mental examination test will be done at baseline for the diagnostic
It takes 30 minutes before the preparation of the surgery
Change the cognitive function #1
Time Frame: It Will be done at the hospital after one day of recovery
The minimental examination test Will be done after one day of the anesthesic procedure.
It Will be done at the hospital after one day of recovery
Change the cognitive function #2
Time Frame: It Will be done at the patient home
The minimental examination test Will be done after one month of the anesthesic procedure.
It Will be done at the patient home
Change the cognitive function#3
Time Frame: It Will be done at the patient home three months after the surgery
The minimental examination test Will be done after three months of the anesthesic procedure.
It Will be done at the patient home three months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Colima

Collaborators

Instituto Mexicano del Seguro Social

Investigators

  • Study Director: Oscar-Alberto Newton-Sanchez, Phd, Universidad de Colima
  • Principal Investigator: Fabian Rojas-Larios, Phd, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2021

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

June 20, 2021

Study Registration Dates

First Submitted

October 5, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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