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Completed

NCT Number: NCT04820595

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

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.

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Key information

Conditions

Emergence Delirium Cognition Disorders Cognitive Dysfunction Confusion Delirium Emergence Agitation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications Postoperative Delirium Signs and Symptoms

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Main Military Clinical Hospital n.a. Acad.N. N. Burdenko, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RASS

Diagnostic Test

Richmond Agitation-Sedation Scale

CAM-ICU

Diagnostic Test

Confusion Assessment Method for the ICU

Primary outcomes

  1. frequency of postoperative delirium

    Time frame: 5 postoperative day

    Percent of postoperative delirium

  2. frequency of postoperative cognitive dysfunction

    Time frame: 7 postoperative day

    Percent of postoperative cognitive dysfunction

Secondary outcomes

  1. frequency of emergence agitation

    Time frame: immediately upon emergence from anesthesia

    Percent of emergence agitation

  2. frequency of emergence delirium

    Time frame: immediately upon emergence from anesthesia

    Percent of emergence delirium

  3. Length of postoperative delirium

    Time frame: 5 postoperative day

    Day of the end of postoperative delirium - day of onset of postoperative delirium

  4. Length of stay in ICU

    Time frame: 1 year

    From ICU admission to ICU discharge

  5. Length of hospitalization

    Time frame: 1 year

    From operative day to hospital discharge

  6. MACE

    Time frame: 30 day

    Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization

  7. MACE

    Time frame: 1 year

    Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization

  8. MACCE

    Time frame: 30 day

    Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident

  9. MACCE

    Time frame: 1 year

    Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident

  10. 30-day mortality

    Time frame: 30 day

    30-day mortality

  11. 1-year mortality

    Time frame: 1 year

    1-year mortality

Sponsors and collaborators

Lead sponsor

Negovsky Reanimatology Research Institute

Other Gov

Registry information

Acronym: PoD

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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