NCT04528537

Brief Summary

Quality of recovery after surgery and anesthesia is an important endpoint in perioperative medicine. Several questionnaires have been developed that assess the patient's perception on postoperative recovery at 24 h after surgery. This study aims to adapt validate the Quality of Recovery 15-questionnaire for application in the postanesthesia care unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 10, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

August 24, 2020

Last Update Submit

October 8, 2021

Conditions

Postoperative Quality of Recovery in the Postanesthesia Care Unit

Outcome Measures

Primary Outcomes (1)

  • 16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)

    Validity of the QoR-PACU

    up to 4 hours following extubation

Interventions

questionnaireOTHER

16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)

Eligibility Criteria

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

Patients scheduled for non-cardiac surgery under general anesthesia in a postanesthesia care unit at a tertiary care hospital

You may qualify if:

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

You may not qualify if:

  • postoperative intensive care unit 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

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

August 10, 2020

Primary Completion

November 23, 2020

Study Completion

December 28, 2020

Last Updated

October 11, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)