Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial

Conditions
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Emergence Delirium, Emergence Agitation, Postoperative Delirium

Intervention / Treatment
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* Diagnostic Test: RASS
* Diagnostic Test: CAM-ICU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Patients who have RASS < +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia | Diagnostic Test: RASS<br>* Richmond Agitation-Sedation Scale<br>Diagnostic Test: CAM-ICU<br>* Confusion Assessment Method for the ICU<br>|
| Agitated non-delirious group<br>Patients who have RASS = +2 or more and have not delirium according CAM-ICU immediately upon emergence from anesthesia | Diagnostic Test: RASS<br>* Richmond Agitation-Sedation Scale<br>Diagnostic Test: CAM-ICU<br>* Confusion Assessment Method for the ICU<br>|
| Agitated delirium group<br>Patients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia | Diagnostic Test: RASS<br>* Richmond Agitation-Sedation Scale<br>Diagnostic Test: CAM-ICU<br>* Confusion Assessment Method for the ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of postoperative delirium | Percent of postoperative delirium | 5 postoperative day | 
| frequency of postoperative cognitive dysfunction | Percent of postoperative cognitive dysfunction | 7 postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of emergence agitation | Percent of emergence agitation | immediately upon emergence from anesthesia | 
| frequency of emergence delirium | Percent of emergence delirium | immediately upon emergence from anesthesia | 
| Length of postoperative delirium | Day of the end of postoperative delirium - day of onset of postoperative delirium | 5 postoperative day | 
| Length of stay in ICU | From ICU admission to ICU discharge | 1 year | 
| Length of hospitalization | From operative day to hospital discharge | 1 year | 
| MACE | Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization | 30 day | 
| MACE | Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization | 1 year | 
| MACCE | Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident | 30 day | 
| MACCE | Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident | 1 year | 
| 30-day mortality | 30-day mortality | 30 day | 
| 1-year mortality | 1-year mortality | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergence agitation, postoperative agitation, postoperative delirium, postoperative cognitive dysfunction, emergence delirium