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A Study of Diclofenac Sodium Suppositories for the Relief of Urinary Catheter-Associated Bladder Discomfort (CRBD) During PACU Awakening in Non-Urological Patients With General Anesthesia

A Study of Diclofenac Sodium Suppositories for the Relief of Urinary Catheter-Associated Bladder Discomfort (CRBD) During PACU Awakening in Non-Urological Patients With General Anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087239
Enrollment
Unknown
Registered
2024-07-23
Start date
2024-07-31
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

catheter-related bladder discomfort

Interventions

treatment group:50mg diclofenac sodium suppository for rectal administration and intravenous injection of 2ml physiological saline
control group:Intravenous administration of 0.04mg/kg oxycodone injection

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2. Electively perform non urological, non cardiac, and non rectal and anal surgeries under general anesthesia; 3. ASA I-III level; 4. BMI18.5-28 kg/m^2; 5. Patients who complain of catheter-related bladder discomfort after removing the endotracheal tube after entering PACU; 6. Elementary school education level or above, able to communicate in Mandarin

Exclusion criteria

Exclusion criteria: 1. The patient developed delirium after waking up in PACU; 2. Patients with multiple failed catheterization and abnormal urethral anatomy; 3. Preoperative cognitive impairment or mental illness in patients; 4. Preoperative complications include neurogenic bladder, urinary tract infection, and bladder outflow tract obstruction; Bladder overactivity syndrome (urinary frequency>3 times/night or 8 times/24 hours); 5. There are individuals who are contraindicated or allergic to the drugs used in the study; 6. Participants in other clinical studies during the same period; 7. Pregnant and lactating patients; 8. The subject has any other diseases that are not suitable for this clinical study

Design outcomes

Primary

MeasureTime frame
the severity of CRBD (CRBD score) decreased compared to baseline;

Secondary

MeasureTime frame
CRBD score at different times;level of CRBD;VAS score;Richmond Agitation and Sedation Scale;Situations requiring remedial measures ;Adverse reaction incidence rate;

Countries

China

Contacts

Public ContactYingqi Weng

Department of Anesthesiology,Xiangya Hospital,Central South University

651922615@qq.com+86 150 7483 4690

Outcome results

None listed

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