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

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ClinicalTrials.gov Identifier: NCT04134052
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Pedro Julian Flores Moreno, Universidad de Colima

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 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.

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Drug: ketamine sedation versus midazolam sedation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Simple finite randomization will be performed. The anesthesiologist will choose an envelope with an assigned folio divided into two groups 1) intravenous infusion midazolam and 2) intravenous infusion ketamine, For sedation, regional anesthesia will be applied and hemodynamic variables, administered drugs, type of surgery, surgery time and transoperative bleeding will be recorded, after that, the cognitive evolution will be evaluated with the minimental examination at 3 months postoperatively
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: the participant, the researcher and the outcomes assesor don't know the drug used for sedation.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 4, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: ketamine sedation




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134052


Contacts
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Contact: karina Espinoza-Mejia, Msc 52-1 312-1164758 kespinoza2@ucol.mx
Contact: Fabian Rojas-Larios, Phd 52-1 312 1206804 frojas@ucol.mx

Locations
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Mexico
Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez Recruiting
Colima, Mexico, 28984
Contact: karina Espinoza-Mejia, Msc    52 1 312 11 64758    kespinoza2@ucol.mx   
Contact: Fabian Rojas-Larios, Phd    52 1 312 12 06804    frojas@ucol.mx   
Sub-Investigator: Jose Guzman-Esquivel, Phd         
Sponsors and Collaborators
Universidad de Colima
Instituto Mexicano del Seguro Social
Investigators
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Study Director: Oscar-Alberto Newton-Sanchez, Phd Universidad de Colima
Principal Investigator: Fabian Rojas-Larios, Phd Universidad de Colima
Publications of Results:
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Responsible Party: Pedro Julian Flores Moreno, Principal investigator, master of medical sciences, Universidad de Colima
ClinicalTrials.gov Identifier: NCT04134052    
Other Study ID Numbers: 090129
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Pedro Julian Flores Moreno, Universidad de Colima:
ketamine
midazolam
cognitive dysfunction
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents