NCT06905353

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 25, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

postoperative carepatient-reported outcome

Outcome Measures

Primary Outcomes (2)

  • Minimal clinically important difference of QoR-PACU2

    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

    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

Study Arms (2)

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

Eligibility Criteria

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

adult patients scheduled for elective non-cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

research group for Clinical Neuroscience in Anesthesiology

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share