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Development and Validation of the Multidimensional Catheter-Related Bladder Discomfort Scale (CRBD-M) and Its Association with Emergence Agitation: A Prospective Cohort Study

Development and Validation of the Multidimensional Catheter-Related Bladder Discomfort Scale (CRBD-M) and Its Association with Emergence Agitation: A Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117315
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-01-24
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-related bladder discomfort (CRBD) is a common complication after general anesthesia, with typical manifestations including burning pain in the bladder area and urethra, strong urge to urinate, suprapubic distension, and repeated attempts to remove the ureter Stay time, reduce patient satisfaction and clinical work efficiency. Emergence agitation (EA) is a common acute state of confusion d

Interventions

Single cohort (observation group):None

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Adult patient, age >= 18; 2.Planned to undergo elective surgery under general anesthesia (which may include urology, gynecology, general surgery, orthopedics, etc.); 3.According to the perioperative management requirements, a urinary catheter needs to be indwelled during or after the operation, with an estimated indwelling time of 6 to 12 hours. 4.Preoperative consciousness is clear, capable of simple communication, understanding and cooperating with scale assessment (answering questions independently or under guidance).

Exclusion criteria

Exclusion criteria: 1.Those who have been clearly diagnosed with severe cognitive dysfunction, dementia or severe mental disorders in the past and cannot cooperate with the scale assessment; 2.Those who have severe lower urinary tract obstruction, neurogenic bladder, etc. before surgery, and have an indwelling catheter; 3.Those who are planned to be transferred directly to the ICU after surgery and cannot undergo routine CRBD/EA assessment during the recovery period; 4.Those who already have obvious agitation, delirium or sedation before surgery; 5.Other conditions that the investigator deems unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Total score and psychometric properties of the Multidimensional Catheter-Related Bladder Discomfort Scale (CRBD-M);

Secondary

MeasureTime frame
Incidence of moderate to severe CRBD-M;Use of rescue sedation/analgesic medication during the awakening period;Traditional CRBD grading (0–3);PACU stay time;Incidence of Emergence Agitation;Postoperative incision pain score;Occurrence of adverse events that may be associated with EA/CRBD;

Countries

China

Contacts

Public ContactJiayuan Li

The Third Affiliated Hospital Sun Yat-sen University

1378189135@qq.com+86 20 8525 3132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026