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Cognitive DysfunctionPhase 3ketaminvsMDZNCT04134052

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

A Phase 3 study testing ketamine sedation versus midazolam sedation in people with Cognitive Dysfunction, run by Universidad de Colima at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Dysfunction
What is being tested?
ketamine sedation versus midazolam sedation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteMexico
Study dates
24 Jan 2021to 20 Jun 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

karina Espinoza-Mejia, Msc contact

52-1 312-1164758

kespinoza2@ucol.mx

Fabian Rojas-Larios, Phd contact

52-1 312 1206804

frojas@ucol.mx

Mexico1 site, 1 recruiting

  • Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez

    Colima, 28984

    karina Espinoza-Mejia, Msc, 52 1 312 11 64758, kespinoza2@ucol.mx

    Fabian Rojas-Larios, Phd, 52 1 312 12 06804, frojas@ucol.mx

    Recruiting

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
ketamine sedation versus midazolam sedation
Keywords
ketamine, midazolam, cognitive dysfunction
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ketamine sedation versus midazolam sedationDrug

    Also called ketamine 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

Study groups in NCT04134052
Study groupRoleWhat they receive
ketamine sedationExperimentalSedation will be performed with ketamine dose 5-20mcg / kg / min in infusion with 100 ml Na Cl solution 0.9% during surgery
Receives: Drug: ketamine sedation versus midazolam sedation
midazolam sedationActive comparatorSedation will be performed with midazolam dose 5 - 35mcg / kg / hr in infusion with 100 ml Na Cl solution 0.9% during surgery
Receives: Drug: ketamine sedation versus midazolam sedation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognitive function at baseline

    the mini mental examination test will be done at baseline for the diagnostic

    Measured: It takes 30 minutes before the preparation of the surgery

  2. Change the cognitive function #1

    The minimental examination test Will be done after one day of the anesthesic procedure.

    Measured: It Will be done at the hospital after one day of recovery

  3. Change the cognitive function #2

    The minimental examination test Will be done after one month of the anesthesic procedure.

    Measured: It Will be done at the patient home

  4. Change the cognitive function#3

    The minimental examination test Will be done after three months of the anesthesic procedure.

    Measured: It Will be done at the patient home three months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start24 Jan 2021
  3. Primary completion15 May 2021 (estimated)
  4. Study completion20 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04134052
Sponsor's protocol ID
090129
Acronym
ketaminvsMDZ
Status last verified
Jan 2021
First submitted
5 Oct 2019
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hogue CW, Grafman J. Aligning nomenclature for cognitive changes associated with anaesthesia and surgery with broader diagnostic classifications of non-surgical populations: a needed first step. Br J Anaesth. 2018 Nov;121(5):991-993. doi: 10.1016/j.bja.2017.12.029. Epub 2018 Jan 17. No abstract available.

    PubMed 30336869

  • Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.

    PubMed 30336844

  • Shoair OA, Grasso Ii MP, Lahaye LA, Daniel R, Biddle CJ, Slattum PW. Incidence and risk factors for postoperative cognitive dysfunction in older adults undergoing major noncardiac surgery: A prospective study. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):30-6. doi: 10.4103/0970-9185.150530.

    PubMed 25788770

  • Li L, Vlisides PE. Ketamine: 50 Years of Modulating the Mind. Front Hum Neurosci. 2016 Nov 29;10:612. doi: 10.3389/fnhum.2016.00612. eCollection 2016.

    PubMed 27965560

  • Paredes S, Cortinez L, Contreras V, Silbert B. Post-operative cognitive dysfunction at 3 months in adults after non-cardiac surgery: a qualitative systematic review. Acta Anaesthesiol Scand. 2016 Sep;60(8):1043-58. doi: 10.1111/aas.12724. Epub 2016 Mar 29.

    PubMed 27027720

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ketamine sedation versus midazolam sedation in people with Cognitive Dysfunction, run by Universidad de Colima at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact karina Espinoza-Mejia, Msc (52-1 312-1164758, kespinoza2@ucol.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognitive function at baseline (time frame: It takes 30 minutes before the preparation of the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04134052, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

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