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

Sponsor
Negovsky Reanimatology Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04820595
Collaborator
(none)
200
Enrollment
2
Locations
26.3
Anticipated Duration (Months)
100
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: RASS
  • Diagnostic Test: CAM-ICU

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
Actual Study Start Date :
Mar 30, 2021
Actual Primary Completion Date :
Jun 9, 2022
Anticipated Study Completion Date :
Jun 9, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. frequency of postoperative delirium [5 postoperative day]

    Percent of postoperative delirium

  2. frequency of postoperative cognitive dysfunction [7 postoperative day]

    Percent of postoperative cognitive dysfunction

Secondary Outcome Measures

  1. frequency of emergence agitation [immediately upon emergence from anesthesia]

    Percent of emergence agitation

  2. frequency of emergence delirium [immediately upon emergence from anesthesia]

    Percent of emergence delirium

  3. Length of postoperative delirium [5 postoperative day]

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

  4. Length of stay in ICU [1 year]

    From ICU admission to ICU discharge

  5. Length of hospitalization [1 year]

    From operative day to hospital discharge

  6. MACE [30 day]

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

  7. MACE [1 year]

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

  8. MACCE [30 day]

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

  9. MACCE [1 year]

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

  10. 30-day mortality [30 day]

    30-day mortality

  11. 1-year mortality [1 year]

    1-year mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 74 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moscow Scientific Clinical Center Moscow Russian Federation 111123
2 Main Military Clinical Hospital n.a. Acad.N. N. Burdenko Moscow Russian Federation

Sponsors and Collaborators

  • Negovsky Reanimatology Research Institute

Investigators

  • Principal Investigator: Valery Likhvantsev, Negovsky Reanimatology Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valery Likhvantsev, MD, Head of the Research Negovsky Reanimatology Research Institute, Negovsky Reanimatology Research Institute
ClinicalTrials.gov Identifier:
NCT04820595
Other Study ID Numbers:
  • PoD-2021
First Posted:
Mar 29, 2021
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Valery Likhvantsev, MD, Head of the Research Negovsky Reanimatology Research Institute, Negovsky Reanimatology Research Institute
emergence agitation
postoperative agitation
postoperative delirium
postoperative cognitive dysfunction
emergence delirium
Additional relevant MeSH terms:
Delirium
Psychomotor Agitation
Emergence Delirium
Emergencies
Cognitive Dysfunction

Study Results

No Results Posted as of Jun 14, 2022