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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04820595
Acronym
PoD
Enrollment
200
Registered
2021-03-29
Start date
2021-03-30
Completion date
2023-06-09
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Emergence Agitation, Postoperative Delirium

Keywords

emergence agitation, postoperative agitation, postoperative delirium, postoperative cognitive dysfunction, emergence delirium

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.

Interventions

DIAGNOSTIC_TESTRASS

Richmond Agitation-Sedation Scale

DIAGNOSTIC_TESTCAM-ICU

Confusion Assessment Method for the ICU

Sponsors

Negovsky Reanimatology Research Institute
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of postoperative delirium5 postoperative dayPercent of postoperative delirium
frequency of postoperative cognitive dysfunction7 postoperative dayPercent of postoperative cognitive dysfunction

Secondary

MeasureTime frameDescription
Length of postoperative delirium5 postoperative dayDay of the end of postoperative delirium - day of onset of postoperative delirium
Length of stay in ICU1 yearFrom ICU admission to ICU discharge
Length of hospitalization1 yearFrom operative day to hospital discharge
frequency of emergence agitationimmediately upon emergence from anesthesiaPercent of emergence agitation
MACCE30 dayCardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident
30-day mortality30 day30-day mortality
1-year mortality1 year1-year mortality
MACE30 dayCardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization
frequency of emergence deliriumimmediately upon emergence from anesthesiaPercent of emergence delirium

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026