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

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

Sponsors

Lead sponsor: Universidad de Colima

Collaborator: Instituto Mexicano del Seguro Social

Source 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.

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.

Overall Status Recruiting
Start Date October 1, 2019
Completion Date October 20, 2020
Primary Completion Date July 4, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
cognitive function at baseline It takes 30 minutes before the preparation of the surgery
Change the cognitive function #1 It Will be done at the hospital after one day of recovery
Change the cognitive function #2 It Will be done at the patient home
Change the cognitive function#3 It Will be done at the patient home three months after the surgery
Enrollment 160
Condition
Intervention

Intervention type: Drug

Intervention name: ketamine sedation versus midazolam sedation

Description: 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

Eligibility

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

Gender: All

Minimum age: 60 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last name: karina Espinoza-Mejia, Msc

Phone: 52-1 312-1164758

Email: [email protected]

Location
facility status contact contact_backup investigator Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez karina Espinoza-Mejia, Msc 52 1 312 11 64758 [email protected] Jose Guzman-Esquivel, Phd Sub-Investigator
Location Countries

Mexico

Verification Date

June 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Universidad de Colima

Investigator full name: Pedro Julian Flores Moreno

Investigator title: Principal investigator, master of medical sciences

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ketamine sedation

Arm group type: Experimental

Description: Sedation will be performed with ketamine dose 5-20mcg / kg / min in infusion with 100 ml Na Cl solution 0.9% during surgery

Arm group label: midazolam sedation

Arm group type: Active Comparator

Description: Sedation will be performed with midazolam dose 5 - 35mcg / kg / hr in infusion with 100 ml Na Cl solution 0.9% during surgery

Acronym ketaminvsMDZ
Patient Data No
Study Design Info

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

Primary purpose: Prevention

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.

Source: ClinicalTrials.gov