NCT04820595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

March 23, 2021

Last Update Submit

July 10, 2023

Conditions

Emergence DeliriumEmergence AgitationPostoperative Delirium

Keywords

emergence agitationpostoperative agitationpostoperative deliriumpostoperative cognitive dysfunctionemergence delirium

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • frequency of emergence agitation

    immediately upon emergence from anesthesia

  • frequency of emergence delirium

    immediately upon emergence from anesthesia

  • Length of postoperative delirium

    5 postoperative day

  • Length of stay in ICU

    1 year

  • Length of hospitalization

    1 year

  • +6 more secondary outcomes

Study Arms (3)

Control group

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

Diagnostic Test: RASSDiagnostic Test: CAM-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: RASSDiagnostic Test: CAM-ICU

Agitated delirium group

Patients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia

Diagnostic Test: RASSDiagnostic Test: CAM-ICU

Interventions

RASSDIAGNOSTIC_TEST

Richmond Agitation-Sedation Scale

Agitated delirium groupAgitated non-delirious groupControl group
CAM-ICUDIAGNOSTIC_TEST

Confusion Assessment Method for the ICU

Agitated delirium groupAgitated non-delirious groupControl group

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from 45 to 74 years old undergoing elective orthopedic surgery

You may qualify if:

  • Age from 45 to 74 years
  • Undergoing elective orthopedic surgery
  • Provide written informed consent to participate in the PoD trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moscow Scientific Clinical Center

Moscow, 111123, Russia

Location

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

Moscow, Russia

Location

MeSH Terms

Conditions

Emergence DeliriumPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersCognitive DysfunctionCognition Disorders

Study Officials

  • Valery Likhvantsev

    Negovsky Reanimatology Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Research Negovsky Reanimatology Research Institute

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 29, 2021

Study Start

March 30, 2021

Primary Completion

June 9, 2022

Study Completion

June 9, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations

RU(2)