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

Completed

• Conditions: Emergence Delirium; Postoperative Delirium; Emergence Agitation
• Interventions: Diagnostic Test: RASS; Diagnostic Test: CAM-ICU

• Registration Number: NCT04820595
• Lead Sponsor: Negovsky Reanimatology Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Study Start: 2021-03-30
• Primary Completion: 2022-06-09
• Study Completion: 2023-06-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Agitated delirium group	RASS	Patients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia
Control group	RASS	Patients who have RASS \< +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia
Agitated non-delirious group	CAM-ICU	Patients who have RASS = +2 or more and have not delirium according CAM-ICU immediately upon emergence from anesthesia
Control group	CAM-ICU	Patients who have RASS \< +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia
Agitated non-delirious group	RASS	Patients who have RASS = +2 or more and have not delirium according CAM-ICU immediately upon emergence from anesthesia
Agitated delirium group	CAM-ICU	Patients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia

Primary Outcome Measures

Name	Time	Method
frequency of postoperative delirium	5 postoperative day	Percent of postoperative delirium
frequency of postoperative cognitive dysfunction	7 postoperative day	Percent of postoperative cognitive dysfunction

Secondary Outcome Measures

Name	Time	Method
frequency of emergence delirium	immediately upon emergence from anesthesia	Percent of emergence delirium
Length of postoperative delirium	5 postoperative day	Day of the end of postoperative delirium - day of onset of postoperative delirium
Length of hospitalization	1 year	From operative day to hospital discharge
MACCE	1 year	Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident
1-year mortality	1 year	1-year mortality
frequency of emergence agitation	immediately upon emergence from anesthesia	Percent of emergence agitation
Length of stay in ICU	1 year	From ICU admission to ICU discharge
MACE	1 year	Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization
30-day mortality	30 day	30-day mortality

Trial Locations

Locations (2)

Moscow Scientific Clinical Center; 🇷🇺 Moscow, Russian Federation

Main Military Clinical Hospital n.a. Acad.N. N. Burdenko; 🇷🇺 Moscow, Russian Federation