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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Emergence Delirium; Emergence Agitation
• Intervention / Treatment: Diagnostic test: RASS; Diagnostic test: CAM-ICU

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111123
    • Moscow Scientific Clinical Center
  • Moscow, Russian Federation
    • Main Military Clinical Hospital n.a. Acad.N. N. Burdenko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients from 45 to 74 years old undergoing elective orthopedic surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Negovsky Reanimatology Research Institute
• Investigators: Principal Investigator: Valery Likhvantsev, Negovsky Reanimatology Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: emergence agitation; postoperative cognitive dysfunction; emergence delirium; postoperative delirium; postoperative agitation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Dyskinesias; Psychomotor Disorders; Cognition Disorders; Delirium; Emergencies; Psychomotor Agitation; Cognitive Dysfunction; Emergence Delirium
• Other Study ID Numbers: PoD-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No