Clinical trial NCT04820595: Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
Official title: Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergence Delirium
Emergence Agitation
Postoperative Delirium
Keywords: emergence agitation
postoperative agitation
postoperative delirium
postoperative cognitive dysfunction
emergence delirium
Lead sponsor: Negovsky Reanimatology Research Institute
Sponsor class: OTHER_GOV
First posted: 2021-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from 45 to 74 years old undergoing elective orthopedic surgery

Brief summary: Perioperative neurocognitive disorders (PND) have been studying by clinicians, particularly by anesthesiologists, pretty long, however the most inspiring advancements were achieved during the last few decades. The most recent classification of PND which includes cognitive decline diagnosed before operation (described as neurocognitive disorder); any form of acute event (postoperative delirium) and cognitive decline diagnosed up to 30 days after the procedure (delayed neurocognitive recovery) and up to 12 months (postoperative neurocognitive disorder) was proposed in 2017. However at will one can notice at least one uncertainty that pertinent to the definition of delirium, emergency delirium and not mentioned in the classification discussed agitation.

The objective of the study is to determine if there is a difference between emergence agitation and emergence delirium.


Eligibility criteria: Inclusion Criteria:

* Age from 45 to 74 years
* Undergoing elective orthopedic surgery
* Provide written informed consent to participate in the PoD trial

Exclusion Criteria:

* Undergoing emergent/urgent surgery
* Montreal Cognitive Assessment \< 18 points
* History of mental disorders according ICD-11
* Treated with at least one psychotropic drug
* Patients with neuromuscular disease
* Inability to undergo preoperative assessment for any reason
* Previously enrolled in PoD trial

Primary outcomes:
measure: frequency of postoperative delirium
timeFrame: 5 postoperative day
measure: frequency of postoperative cognitive dysfunction
timeFrame: 7 postoperative day
Secondary outcomes:
measure: frequency of emergence agitation
timeFrame: immediately upon emergence from anesthesia
measure: frequency of emergence delirium
timeFrame: immediately upon emergence from anesthesia
measure: Length of postoperative delirium
timeFrame: 5 postoperative day
measure: Length of stay in ICU
timeFrame: 1 year
measure: Length of hospitalization
timeFrame: 1 year
measure: MACE
timeFrame: 30 day
measure: MACE
timeFrame: 1 year
measure: MACCE
timeFrame: 30 day
measure: MACCE
timeFrame: 1 year
measure: 30-day mortality
timeFrame: 30 day
measure: 1-year mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Scientific Clinical Center
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital n.a. Acad.N. N. Burdenko
Study officials:
affiliation: Negovsky Reanimatology Research Institute
name: Valery Likhvantsev
role: PRINCIPAL_INVESTIGATOR
References: