Emergence DeliriumPoDNCT04820595
Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
An observational study of Emergence Delirium and Emergence Agitation, run by Negovsky Reanimatology Research Institute at 2 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Emergence Delirium, Emergence Agitation, Postoperative Delirium
- What is being tested?
- RASS and CAM-ICU
- How many people
- 200 participants
- Where
- 2 sitesRussia
- Study dates
- 30 Mar 2021to 9 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from 45 to 74 years old undergoing elective orthopedic surgery
Who may be able to join
- Age from 45 to 74 years
- Undergoing elective orthopedic surgery
- Provide written informed consent to participate in the PoD trial
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Russia2 sites
Moscow Scientific Clinical Center
Moscow, 111123
Main Military Clinical Hospital n.a. Acad.N. N. Burdenko
Moscow
About this study
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.
- Being tested
- RASS, CAM-ICU
- Keywords
- emergence agitation, postoperative agitation, postoperative delirium, postoperative cognitive dysfunction, emergence delirium
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RASSDiagnostic test
Richmond Agitation-Sedation Scale
CAM-ICUDiagnostic test
Confusion Assessment Method for the ICU
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients who have RASS < +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia Receives: Diagnostic Test: RASS; Diagnostic 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 Receives: Diagnostic Test: RASS; Diagnostic Test: CAM-ICU | |
| Agitated delirium group | Patients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia Receives: Diagnostic Test: RASS; Diagnostic Test: CAM-ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of postoperative delirium
Percent of postoperative delirium
Measured: 5 postoperative day
frequency of postoperative cognitive dysfunction
Percent of postoperative cognitive dysfunction
Measured: 7 postoperative day
Secondary outcomes (11)
frequency of emergence agitation
Percent of emergence agitation
Measured: immediately upon emergence from anesthesia
frequency of emergence delirium
Percent of emergence delirium
Measured: immediately upon emergence from anesthesia
Length of postoperative delirium
Day of the end of postoperative delirium - day of onset of postoperative delirium
Measured: 5 postoperative day
Length of stay in ICU
From ICU admission to ICU discharge
Measured: 1 year
Length of hospitalization
From operative day to hospital discharge
Measured: 1 year
MACE
Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization
Measured: 30 day
MACE
Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization
Measured: 1 year
MACCE
Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident
Measured: 30 day
MACCE
Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident
Measured: 1 year
30-day mortality
30-day mortality
Measured: 30 day
1-year mortality
1-year mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start30 Mar 2021
- Primary completion9 Jun 2022
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Negovsky Reanimatology Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery Likhvantsev, MD, Negovsky Reanimatology Research Institute
- Investigators
- Valery Likhvantsev, Principal investigator, Negovsky Reanimatology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820595
- Sponsor's protocol ID
- PoD-2021
- Acronym
- PoD
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
- ClinicalTrials.gov ID
- NCT04820595
- Acronym / sponsor ID
- PoD / PoD-2021
- Keywords
- emergence agitation, postoperative agitation, postoperative delirium, postoperative cognitive dysfunction, emergence delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Negovsky Reanimatology Research InstituteOther government
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: RASS, Diagnostic Test: CAM-ICUPatients who have RASS < +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia |
| Agitated non-delirious group | – | Diagnostic Test: RASS, Diagnostic Test: CAM-ICUPatients who have RASS = +2 or more and have not delirium according CAM-ICU immediately upon emergence from anesthesia |
| Agitated delirium group | – | Diagnostic Test: RASS, Diagnostic Test: CAM-ICUPatients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 45 to 74 years old undergoing elective orthopedic surgery
Key inclusion criteria (3 listed)
- Age from 45 to 74 years
- Undergoing elective orthopedic surgery
- Provide written informed consent to participate in the PoD trial
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RASSRichmond Agitation-Sedation Scale | Diagnostic test | Agitated delirium group, Agitated non-delirious group, Control group |
| CAM-ICUConfusion Assessment Method for the ICU | Diagnostic test | Agitated delirium group, Agitated non-delirious group, Control group |
Primary outcome
frequency of postoperative delirium
Time frame: 5 postoperative day
Percent of postoperative delirium
frequency of postoperative cognitive dysfunction
Time frame: 7 postoperative day
Percent of postoperative cognitive dysfunction
11 secondary outcomes
frequency of emergence agitation
Time frame: immediately upon emergence from anesthesia
frequency of emergence delirium
Time frame: immediately upon emergence from anesthesia
Length of postoperative delirium
Time frame: 5 postoperative day
Length of stay in ICU
Time frame: 1 year
Length of hospitalization
Time frame: 1 year
MACE
Time frame: 30 day
MACE
Time frame: 1 year
MACCE
Time frame: 30 day
MACCE
Time frame: 1 year
30-day mortality
Time frame: 30 day
1-year mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valery Likhvantsev principal investigator
Negovsky Reanimatology Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium and Emergence Agitation, run by Negovsky Reanimatology Research Institute at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of postoperative delirium (time frame: 5 postoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.