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

NCT ID: NCT04134052

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-24
• Study Completion Date: 2021-06-20

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.

Conditions

Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ketamine sedation

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

Group Type: EXPERIMENTAL

ketamine sedation versus midazolam sedation

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

ketamine sedation versus midazolam sedation

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: collaborator

Universidad de Colima

OTHER

Sponsor Role: lead

Responsible Party

Pedro Julian Flores Moreno

Principal investigator, master of medical sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oscar-Alberto Newton-Sanchez, Phd

Role: STUDY_DIRECTOR

Universidad de Colima

Fabian Rojas-Larios, Phd

Role: PRINCIPAL_INVESTIGATOR

Universidad de Colima

Locations

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

Colima, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

karina Espinoza-Mejia, Msc

Role: CONTACT

kespinoza2@ucol.mx

52-1 312-1164758

Fabian Rojas-Larios, Phd

Role: CONTACT

frojas@ucol.mx

52-1 312 1206804

Facility Contacts

karina Espinoza-Mejia, Msc

Role: primary

kespinoza2@ucol.mx

52 1 312 11 64758

Fabian Rojas-Larios, Phd

Role: backup

frojas@ucol.mx

52 1 312 12 06804

References

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.

Reference Type: RESULT

PMID: 30336869 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30336844 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25788770 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27965560 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27027720 (View on PubMed)

Other Identifiers

090129

Identifier Type: -

Identifier Source: org_study_id