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Determination of the 50% Effective Dose of S-Ketamine for Treating Catheter-Related Bladder Discomfort During the Post-Anesthesia Recovery Period: A Single-Arm Study

Determination of the 50% Effective Dose of S-Ketamine for Treating Catheter-Related Bladder Discomfort During the Post-Anesthesia Recovery Period: A Single-Arm Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108178
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-10-08
Completion date
Unknown
Last updated
2025-09-01

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

Esketamine Treatment Group:For patients with moderate CRBD, the treatment dose was determined using the Dixon up-and-down sequential allocation method with a step size of 0.025 mg/kg. The first patien

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 65 years; 2. American Society of Anesthesiologists (ASA) Physical Status Class I or II; 3. Postoperative indwelling urinary catheter following urological surgery; 4. Diagnosis of moderate Catheter-Related Bladder Discomfort (CRBD) after extubation (removal of endotracheal tube) or removal of the laryngeal mask airway; 5. Recovery in the Post-Anesthesia Care Unit (PACU).

Exclusion criteria

Exclusion criteria: 1. Chronic pain or history of opioid abuse; 2. Bladder outflow obstruction; 3. Urinary tract infection; 4. Heart failure (ejection fraction 180/100 mmHg); 6. Cardiac arrhythmias (e.g., sinus bradycardia, heart block, atrial fibrillation); 7. Elevated intracranial pressure and central nervous system injury or disease; 8. History of or current severe psychiatric disorder; 9. Elevated intraocular pressure (e.g., glaucoma) or penetrating eye injury; 10. Untreated or inadequately controlled hyperthyroidism; 11. Liver cirrhosis; 12. Chronic kidney disease; 13. Overactive bladder (nocturia >3 times/night or urinary frequency >8 times/24 hours); 14. Morbid obesity (Body Mass Index, BMI > 40); 15. Known hypersensitivity to the active substance (esketamine) or any excipient of the drug.

Design outcomes

Primary

MeasureTime frame
median effective dose;

Secondary

MeasureTime frame
90% effective dose;Esketamine-Associated Adverse Effects;

Countries

China

Contacts

Public ContactZhaoli Wang

Peking University Shenzhen Hospital

wzhli86@126.com+86 136 8232 1293

Outcome results

None listed

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