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

NCT04134052 | Unknown Phase 3 DMC

• 1 other identifier: 090129
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

ketamine; midazolam; cognitive dysfunction

Outcome Measures

Primary Outcomes (4)

• cognitive function at baseline

  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

  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

  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

  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

Study Arms (2)

ketamine sedation

EXPERIMENTAL

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

midazolam sedation

ACTIVE COMPARATOR

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

Interventions

ketamine sedation versus midazolam sedation DRUG

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

Also known as: ketamine sedation

ketamine sedation; midazolam sedation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Colima: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

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

Colima, 28984, Mexico

RECRUITING

Related Publications (5)

• 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.

  PMID: 30336869 RESULT

• 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.

  PMID: 30336844 RESULT

• 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.

  PMID: 25788770 RESULT

• 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.

  PMID: 27965560 RESULT

• 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.

  PMID: 27027720 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Oscar-Alberto Newton-Sanchez, Phd

  Universidad de Colima

  STUDY DIRECTOR

• Fabian Rojas-Larios, Phd

  Universidad de Colima

  PRINCIPAL INVESTIGATOR

Central Study Contacts

karina Espinoza-Mejia, Msc

CONTACT

52-1 312-1164758; kespinoza2@ucol.mx

Fabian Rojas-Larios, Phd

CONTACT

52-1 312 1206804; frojas@ucol.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the participant, the researcher and the outcomes assesor don't know the drug used for sedation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, master of medical sciences

Model Details: 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

Study Record Dates

• First Submitted: October 5, 2019
• First Posted: October 21, 2019
• Study Start: January 24, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 20, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)