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

Postoperative Delirium Clinical Trial

— PoD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820595
• Other study ID #: PoD-2021
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: June 9, 2023

Study information

• Verified date: July 2023
• Source: Negovsky Reanimatology Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Emergence Agitation
• Emergence Delirium
• Emergencies
• Postoperative Delirium
• Psychomotor Agitation

Intervention

Diagnostic Test:
• RASS
Richmond Agitation-Sedation Scale
• CAM-ICU
Confusion Assessment Method for the ICU

Locations

Country	Name	City	State
Russian Federation	Main Military Clinical Hospital n.a. Acad.N. N. Burdenko	Moscow
Russian Federation	Moscow Scientific Clinical Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Negovsky Reanimatology Research Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of postoperative delirium	Percent of postoperative delirium	5 postoperative day
Primary	frequency of postoperative cognitive dysfunction	Percent of postoperative cognitive dysfunction	7 postoperative day
Secondary	frequency of emergence agitation	Percent of emergence agitation	immediately upon emergence from anesthesia
Secondary	frequency of emergence delirium	Percent of emergence delirium	immediately upon emergence from anesthesia
Secondary	Length of postoperative delirium	Day of the end of postoperative delirium - day of onset of postoperative delirium	5 postoperative day
Secondary	Length of stay in ICU	From ICU admission to ICU discharge	1 year
Secondary	Length of hospitalization	From operative day to hospital discharge	1 year
Secondary	MACE	Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization	30 day
Secondary	MACE	Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization	1 year
Secondary	MACCE	Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident	30 day
Secondary	MACCE	Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident	1 year
Secondary	30-day mortality	30-day mortality	30 day
Secondary	1-year mortality	1-year mortality	1 year