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

Cognitive Dysfunction Clinical Trial

— ketaminvsMDZ  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134052
• Other study ID #: 090129
• Status: Recruiting
• Phase: Phase 3
• Start date: January 24, 2021
• Est. completion date: June 20, 2021

Study information

• Verified date: January 2021
• Source: Universidad de Colima
• Contact: karina Espinoza-Mejia, Msc
• Phone: 52-1 312-1164758
• Email: kespinoza2[@]ucol.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 20, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
Mexico	Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez	Colima

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Colima	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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 — View Citation

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.20 — View Citation

Li L, Vlisides PE. Ketamine: 50 Years of Modulating the Mind. Front Hum Neurosci. 2016 Nov 29;10:612. eCollection 2016. Review. — View Citation

Paredes S, Cortínez 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 — View Citation

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;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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