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

NCT ID: NCT04820595

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2023-06-09

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.

Detailed Description

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Conditions

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Emergence Delirium Emergence Agitation Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Patients who have RASS \< +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia

RASS

Intervention Type DIAGNOSTIC_TEST

Richmond Agitation-Sedation Scale

CAM-ICU

Intervention Type DIAGNOSTIC_TEST

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

RASS

Intervention Type DIAGNOSTIC_TEST

Richmond Agitation-Sedation Scale

CAM-ICU

Intervention Type DIAGNOSTIC_TEST

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

RASS

Intervention Type DIAGNOSTIC_TEST

Richmond Agitation-Sedation Scale

CAM-ICU

Intervention Type DIAGNOSTIC_TEST

Confusion Assessment Method for the ICU

Interventions

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RASS

Richmond Agitation-Sedation Scale

Intervention Type DIAGNOSTIC_TEST

CAM-ICU

Confusion Assessment Method for the ICU

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Negovsky Reanimatology Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Valery Likhvantsev, MD

Head of the Research Negovsky Reanimatology Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valery Likhvantsev

Role: PRINCIPAL_INVESTIGATOR

Negovsky Reanimatology Research Institute

Locations

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Moscow Scientific Clinical Center

Moscow, , Russia

Site Status

Main Military Clinical Hospital n.a. Acad.N. N. Burdenko

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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PoD-2021

Identifier Type: -

Identifier Source: org_study_id

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