NCT04733703

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

September 28, 2020

Last Update Submit

October 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 hours postoperatively

Interventions

assessment of postoperative quality of recovery with the QoR-15

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who are scheduled for elective non-cardiac surgery and who will receive general anesthesia, are eligible for study participation.

You may qualify if:

  • elective non-cardiac surgery
  • general anesthesia
  • fluency in German

You may not qualify if:

  • expected postoperative ICU stay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Delirium

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marlene Fischer, MD, PhD

    Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlene Fischer, MD, PhD

CONTACT

Christian Zöllner, MD, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

February 2, 2021

Study Start

October 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations