Postoperative Neurocognitive DisordersNCT04733703
Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery
An observational study of Postoperative Neurocognitive Disorders and Delirium, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Neurocognitive Disorders, Delirium, Postoperative Recovery
- What is being tested?
- questionnaire
- How many people
- 278 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2021to Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are scheduled for elective non-cardiac surgery and who will receive general anesthesia, are eligible for study participation.
Who may be able to join
- elective non-cardiac surgery
- general anesthesia
- fluency in German
Who cannot join
- expected postoperative ICU stay
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. So far it is unknown, whether patients with PACU delirium experience impaired postoperative quality of recovery.
The aim of this observational study is to assess the impact of PACU delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.
- Being tested
- questionnaire
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
assessment of postoperative quality of recovery with the QoR-15
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative quality of recovery
patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study startOct 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Fischer, MD, PhD, Principal investigator, Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733703
- Sponsor's protocol ID
- PACQoR 2
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery
- ClinicalTrials.gov ID
- NCT04733703
- Acronym / sponsor ID
- PACQoR 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 2 Feb 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.
Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. So far it is unknown, whether patients with PACU delirium experience impaired postoperative quality of recovery.
The aim of this observational study is to assess the impact of PACU delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are scheduled for elective non-cardiac surgery and who will receive general anesthesia, are eligible for study participation.
Key inclusion criteria (3 listed)
- elective non-cardiac surgery
- general anesthesia
- fluency in German
Key exclusion criteria (1 listed)
- expected postoperative ICU stay
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 |
|---|---|---|
| questionnaireassessment of postoperative quality of recovery with the QoR-15 | Other | – |
Primary outcome
postoperative quality of recovery
Time frame: 24 hours postoperatively
patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Marlene Fischer, MD, PhD principal investigator
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Neurocognitive Disorders and Delirium, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlene Fischer, MD, PhD (+4915222827500, mar.fischer@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative quality of recovery (time frame: 24 hours postoperatively). 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 12 Oct 2021.