Quality of Recovery in the Post-anesthesia Care Unit (MiDiQoR)

March 25, 2025 updated by: Universitätsklinikum Hamburg-Eppendorf

Quality of Recovery in the Post-anesthesia Care Unit - Minimal Clinically Important Difference and Correlation with Postoperative Quality of Recovery One Day After Non-cardiac Surgery

This prospective observational study aims to identify the minimal clinically important difference of the QoR-PACU2 questionnaire. In addition, this study aims to assess the correlation between self-reported quality of postoperative recovery early after surgery in the post-anesthesia care unit and postoperative recovery on the first day after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: research group for Clinical Neuroscience in Anesthesiology
  • Phone Number: +49 40 7410 52415
  • Email: mar.fischer@uke.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients scheduled for elective non-cardiac surgery

Description

Inclusion Criteria:

  • elective non-cardiac surgery
  • expected duration of surgery ≥60 minutes
  • postoperative stay at the post-anesthesia care unit

Exclusion Criteria:

  • surgery or condition requiring postoperative treatment at an intensive care unit
  • inability to give informed consent/requirement of a legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MCID
patients that will answer the QoR-PACU2 twice with anchor questions to identify the minimal clinically important difference
correlation
patients that will additionally answer the QoR-15GE before surgery and on postoperative day one

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal clinically important difference of QoR-PACU2
Time Frame: From preoperative assessment to the day of surgery in the post-anesthesia care unit
The minimal difference in the QoR-PACU2 scores that is relevant for the patient
From preoperative assessment to the day of surgery in the post-anesthesia care unit
correlation between quality of recovery at two time points of assessment
Time Frame: from the day of surgery to the first postoperative day
The correlation between quality of recovery in the post-anesthesia care unit and quality of recovery on postoperative day one
from the day of surgery to the first postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-101434-BO-ff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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