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

Phase 3

• Conditions: Cognitive Dysfunction
• Interventions: Drug: ketamine sedation versus midazolam sedation

• Registration Number: NCT04134052
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2019-10-05
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Status Verified: 2021-01
• Study Start: 2021-01-24
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26
• Primary Completion: 2021-05-15
• Study Completion: 2021-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change the cognitive function #1	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.
Change the cognitive function #2	It Will be done at the patient home	The minimental examination test Will be done after one month of the anesthesic procedure.
cognitive function at baseline	It takes 30 minutes before the preparation of the surgery	the mini mental examination test will be done at baseline for the diagnostic
Change the cognitive function#3	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.

Trial Locations

Locations (1)

Mexican Social Security Institute. General Hospital of Zone 1 Villa de Alvarez; 🇲🇽 Colima, Mexico