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

Negovsky Reanimatology Research Institute

Status: Completed

Conditions: Emergence Agitation; Emergence Delirium; Postoperative Delirium

Treatments: Diagnostic Test: RASS; Diagnostic Test: CAM-ICU

Study type: Observational

Funder types: Other

Identifiers

NCT04820595

PoD-2021

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 45 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Control group

Description:

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

Treatment:

Diagnostic Test: CAM-ICU

Diagnostic Test: RASS

Agitated non-delirious group

Description:

Patients who have RASS = +2 or more and have not delirium according CAM-ICU immediately upon emergence from anesthesia

Treatment:

Diagnostic Test: CAM-ICU

Diagnostic Test: RASS

Agitated delirium group

Description:

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

Treatment:

Diagnostic Test: CAM-ICU

Diagnostic Test: RASS